Customer Service Lead

Reports To: Director Business Development

Company Overview

Beeken Biomedical is a medical device company focused on the development, licensing, and commercialization of products in the surgical, acute, and wound care markets. Beeken’s portfolio of FDA cleared and patent protected technologies include, NuStat®, NuStat XR® and NuStat Flex®.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of health care by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

Key Objectives

Prepares customer quotation requests, orders, customer database and reports, as required. Performs market research to investigate other potential products, services or markets. Ensures the sales and inventory records are adequately maintained. Perform follow-ups with customers and leads on a timely basis. Liaise with other departments processing information in regards to customer requirements. Communicate with customers by phone, email, or in person to process purchase orders. Also, responsible for performing contract reviews and process contract changes.

Primary Duties & Responsibilities

  • Answer incoming customer inquiries; interfacing with other departments, as necessary.
  • Assist in order fulfillment process
  • Accurately enters all customer order requests and verify for accuracy.
  • Processes returns, special account instructions, discounts, and sales promotions.
  • Maintain customer relationships and obtain customer feedback.
  • Collaborate with teams and stay updated on new products, services, and policies.
  • Record customer information within databases.
  • Engage with clients in a friendly and professional manner while actively listening to their concerns. Offer support and solutions to customers.
  • Participate in the investigation and resolution of customer complaints.
  • Other duties as requested.

Qualifications, Knowledge, Skills and Abilities

  • Bachelor’s degree or 3-5 years of relevant work experience
  • Excellent verbal and written communication skills (business technique, grammar, accuracy).
  • Displays appropriate attitude, actions and work attire for the position. Demonstrates commitment, dedication and a positive attitude.
  • Personable with superior interpersonal skills for interacting with all levels of the organization.
  • Highly organized, attention to detail, and ability to follow through is required.
  • Demonstrated computer skills, specifically using Microsoft Office products.
  • Ability to multi-task and adapt to changing priorities with flexibility while maintaining project management and deadlines.
  • Ability to work independently and on a team in a fast-paced environment.
  • Ability to exercise sound judgment and maintain confidentiality on a wide variety of topics for which discretion is required.
  • Orderly, resourceful, and results oriented.

Employee Benefits

Beeken Biomedical values its employees and is working hard to become an employer of choice. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental, and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the Plan is fully paid by the Company
  • Flexible Spending Accounts: Several Flexible Spending Plan options

Document Control Specialist

Department: Quality Assurance
Reports To: Quality Assurance Manager
Supervises: None
Status: Non-Exempt

Company Overview

Beeken Biomedical is a medical device company focused on the development, licensing, and commercialization of products in the surgical, acute, and wound care markets. Beeken’s portfolio of FDA cleared and patent protected technologies include, NuStat®, NuStat XR® and NuStat Flex®.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of health care by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

Primary Responsibility

Provide support for the management and control of quality system documentation and the employee training program in compliance with all internal policies and applicable regulatory requirements.

General Responsibilities

  • Support the management of the Document Control Process per QSP001 Document and Data Management including but not limited to;
    • Review Document Change Request (DCR) packages to ensure all processed documents comply with relevant policies and procedures.
    • Update Bills of Materials as required per DCR.
    • Ensure /DCR training and implementation plans are complete, and notification of approved and closed DCR’s is communicated in a timely manner.
    • Ensure the latest released revisions of documents are available to users electronically, remove and archive prior revisions from point of use.
    • Ensure quality records, including master hard copies, are maintained per established policies and procedures
  • Collaborate with marketing, regulatory, and engineering to design product and packaging labels for new product development and sustaining products compliant with regulatory requirements and with internal policies and procedures for labeling.
  • Create label drawings using appropriate drawing software.
  • Collaborate with marketing and subcontractors to develop and implement new and changed labeling and associated documentation.   Assure documentation is fully released and placed in the document control systems internally and at the subcontractor.
  • Create and process through to completion label change requests and DCRs to release new and revised labeling.
  • Support coordination of backroom activities in preparation and during regulatory audits.
  • Create and maintain SOPs primarily related to Document Control as well as other SOPs that include document control elements.
  • Support the maintenance of the employee training database to track employee training requirements from initial notification of training requirements to completion.
  • Provide data for metrics reporting as required.
  • Assist in the coordination of presentations and the development of presentation material for training programs.
  • Implement UDI in compliance with FDA and EU requirements. Implement other device marking systems.

Qualifications, Knowledge, Skills and Abilities

  • Self-starter with the ability to contribute with minimal supervision
  • Strong organizational and project management skills
  • Minimum of 3 years’ experience in documentation control within the medical device or pharmaceutical industry
  • Working knowledge of FDA 13485 and FDA 21CFR820, MDR requirements.  Knowledge of Canadian and Australian regulatory requirements for documentation a plus.
  • Working knowledge of medical device documents including Device Master Records, BOM’s, Design History Files, Device History Files, and DCR’s.
  • Working knowledge of engineering design and file formats.
  • Proficiency with Word, Excel, Power Point.
  • Implemented and has working knowledge of UDI (U.S and E.U) , GTIN, and GS1.

Employee Benefits

Beeken Biomedical values its employees and is working hard to become an employer of choice. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental, and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the Plan is fully paid by the Company
  • Flexible Spending Accounts: Several Flexible Spending Plan option

Document Control Supervisor

Department: Quality Assurance
Reports To: Manager or Director of Quality Assurance
Supervises: Document Control Specialist, Label Coordinator
Status: Exempt

Company Overview

Beeken Biomedical is a medical device company focused on the development, licensing, and commercialization of products in the surgical, acute, and wound care markets. Beeken’s portfolio of FDA cleared and patent protected technologies include, NuStat®, NuStat XR® and NuStat Flex®.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of health care by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

Primary Responsibility

Supervise the staff and processes related to the processing, management and control of quality system documentation and the employee training program and maintain these in compliance with FDA QSR, ISO 13485, MDR and other applicable regulatory requirements.

General Responsibilities

  • Supervises the staff and processes to manage the Document Control system per QSP001, Document and Data Control, including, but not limited to:
  • Review Document Change Requests (DCR’s) packages to ensure all processed documents comply with Beeken policies and procedures.
  • Update Bill of Materials (BOM) as required per DCR.
  • Ensure DCR training and implementation plans are complete, and notification of approved and closed DCR’s is communicated in a timely manner as required per DCR.
  • Ensure released documents are copied to the electronic document repository and that the latest released version of all documents is readily available to the user and prior revisions are removed from the point of use.
    • Review Drawings and Files as required per DCR.
  • Ensure quality records, including master hard copies are maintained per Beeken policies and procedures.
  • Coordinate translations and outside design services as necessary to meeting product labeling requirements.
  • Collaborate with marketing, regulatory, and engineering to design product and packaging labels for new product development and sustaining products compliant with regulatory requirements and with internal policies and procedures for labeling.
  • Create label drawings as required.
  • Work collaboratively with subcontractors to develop and implement new and changed labels and documentation.
  • Create and process through to completion, Label Change Requests (LCR) and DCRs to release new and revised labeling.
  • Maintain folder hierarchy, access controls and workflows of Product Data Management (PDM) system.
  • Lead in the implementing UDI and other coding in accordance with US and foreign regulatory requirements.
  • Coordinate the backroom setup in preparation for regulatory, third party, and supplier audits.
  • Participate in audits and inspection of the Quality System by regulatory authorities and contract auditors.
  • Create and maintain Standard Operating Procedures (SOP) and General Procedures (GP) relating to Document Control, Control of Records, Employee Training, and other areas as required.
  • Assure the employee training database is current and accurately tracks employee training requirements from notification through to completion. Produce monthly training metrics.
  • Assist in the coordination of presentations and develop presentation material for group training programs as required.
  • Other duties as assigned.

Qualifications, Knowledge, Skills and Abilities

  • Self-starter with the ability to contribute with minimal supervision.
  • Strong organizational and project management skills
  • Proficiency with Microsoft Office Suite, Adobe Acrobat, Illustrator and lnDesign, Bartender or other label design software, SolidWorks and Product Data Management (PDM) and/or other Document Control systems.
  • In depth knowledge of Document Control and Engineering Change Systems.
  • Experience preparing training presentations.
  • Capable of producing reports and graphs tracking and trending quality metrics.
  • Coordination of employee training programs, preferably database driven.
  • Basic knowledge of Beeken product functions, design, and intended use.
  • Understanding of 510k cleared and CE Mark approved indications for use for products.
  • Knowledge of Device Master Records, BOM’s, Device History Files, Design History Files, Document Change and Control.

Employee Benefits

Beeken Biomedical values its employees and is working hard to become an employer of choice. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental, and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the Plan is fully paid by the Company
  • Flexible Spending Accounts: Several Flexible Spending Plan options

Quality Systems Manager – Medical Devices

Department: Quality Assurance
Reports To: CEO, VP of Quality and Regulatory
Supervises: Document Control Supervisor, Document Control Specialist
Status: Exempt

Company Overview

Beeken Biomedical is a medical device company focused on the development, licensing, and commercialization of products in the surgical, acute, and wound care markets. Beeken’s portfolio of FDA cleared and patent protected technologies include, NuStat®, NuStat XR® and NuStat Flex®.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of health care by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

Primary Responsibility

The Quality Systems Manager will coordinate and maintain new and current product lines by providing technical support for quality system compliance for the design, development, production, and distribution of hemostatic dressings.   The QS Manager is responsible for the management and execution of all aspects of the Quality Management System in compliance with FDA Quality System Regulations and ISO 13485 and other applicable regulatory requirements.

General Responsibilities

  • Primary liaison with Suppliers and Contract Manufacturers on quality, design control, manufacturing, and technical matters on new and current products from early design through release to market. Participate in supplier selection, qualification, and
  • Supervise documentation control and label functions and staff. Maintain comprehensive current and historical quality system documentation.
  • Supervise quality assurance staff.
  • Assure new and/or modified products consistently meet specifications and conform to applicable regulatory and quality requirements and standards.
  • Conduct or coordinate audits of external contractors and suppliers. .
  • Responsible for internal quality system
  • Develop and maintain internal QS and supplier audit schedules.
  • Participate in FDA inspections and other regulatory body audits of company facilities.
  • Serves as Management Representative.
  • Establish inspection and sampling requirements for validations, incoming inspection, and final product release in house and at contract manufacturers.
  • Responsible for device history record and sterilization record review and release of product for commercial
  • Schedule and lead management reviews of the Quality System.
  • Support and/or conduct comprehensive Verification and Validation activities for new, modified, and current products, including sterilization, biocompatibility, and packaging, validations. Analyzes and interprets test and validation reports.
  • Responsible for developing and reporting quality metrics.
  • Oversee the development, execution and reporting of laboratory and bench testing protocols.
  • Identify quality system training needs and perform/ coordinate training.
  • Establish, maintain and report on quality system metrics.
  • Oversee the Risk Management system and update risk analysis as needed to keep current with post market surveillance and other internal and external feedback.
  • Actively manage processes and documentation related to the QMS including Complaints, CAPAs, Calibration, Post Market Surveillance, Internal/External Audits
  • Investigate product complaints and conduct failure analysis of returned product.
  • Coordinate the resolution of non-conforming materials and corrective actions.
  • Develop and maintain Design Failure Mode Effect Analysis (DFMEA)

Qualifications, Knowledge, Skills and Abilities

  • Bachelor’s degree in engineering or science preferred.
  • At least 5 years of quality system experience in the medical device field
  • Experience with Suppliers, Contract Manufacturing, Packaging and Sterilization a must
  • Demonstrated knowledge of FDA Quality System Regulations, ISO 13485 Quality System Standard, ISO 14971, MDR.
  • Knowledge of Design Control and Risk Management processes
  • Demonstrated ability to effectively interact and build relationships with company personnel and outside sub-contractors at all levels.
  • Able to work independently without supervision to achieve corporate goals and objectives.
  • Strong oral and written communication skills. Proficient with Word and Excel.
  • Ability to work cross-functionally in a small medical device environment.
  • Some travel may be required to support supplier/laboratory audits and project related reports.

Employee Benefits

Beeken Biomedical values its employees and is working hard to become an employer of choice. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental, and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the Plan is fully paid by the Company
  • Flexible Spending Accounts: Several Flexible Spending Plan options
  • Company Stock Options (must be board approved)

Executive Assistant

Reports To: President/CEO

Company Overview

Beeken Biomedical is a medical device company focused on the development, licensing, and commercialization of products in the surgical, acute, and wound care markets. Beeken’s portfolio of FDA cleared and patent protected technologies include, NuStat®, NuStat XR® and NuStat Flex®.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of health care by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

Primary Responsibility

The Executive Assistant is responsible for delivering a high level of support to the Chief Executive Officer and other executives as needed, facilitating the efficient operation of the company by providing comprehensive office management support. Serves as liaison between employees and visitors as needed. Possesses organizational abilities to effectively perform assigned work.

General Responsibilities

  • Performs office tasks including answering phones, responding to inquiries, taking messages, maintaining records, and ordering supplies as needed.
  • Manages calendars including scheduling in person and virtual meetings, preparing meeting materials and arranging audio/video equipment as needed.
  • Performs clerical and administrative tasks including drafting outgoing correspondence and reviewing incoming correspondence taking action as needed.
  • Serves as first point of contact welcoming employees and visitors.
  • Responds to and resolves administrative inquiries.
  • Arranges corporate travel, meetings, lunches, and other events.
  • Receives and processes assigned expense reports and invoices.
  • Establishes systems and workflow for all activities related to this position.
  • Performs other tasks and projects as assigned.

Qualifications, Knowledge, Skills and Abilities

An Associate’s degree plus at least five years’ experience in an Executive Assistant role is preferred, or an equivalent combination of education and experience.

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of skills and abilities.

  • Excellent interpersonal skills with the ability to interact and work effectively with employees, visitors and vendors with poise and diplomacy, and a high level of confidentiality and discretion.
  • Ability to project a positive and professional image on behalf of the company.
  • Strong written and verbal communication skills including the ability to create and format documents and presentations.
  • Excellent organization skills with strong attention to detail using advanced proofreading skills.
  • Ability to adapt to changes in the work environment, prioritizing and managing competing priorities to meet deadlines.
  • Ability to take direction and exercise sound judgment when making decisions.
  • Demonstrate sound judgment and maintain confidentiality on a wide variety of topics for which discretion is required.

Employee Benefits

Beeken Biomedical values its employees and is working hard to become an employer of choice. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental, and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the Plan is fully paid by the Company
  • Several Flexible Spending Plan options

Hospital Product Manager

Reports To: President/CEO

Company Overview

Beeken Biomedical is a medical device company focused on the development, licensing, and commercialization of hemostasis products in the acute, ambulatory surgical and pre-hospital markets. Beeken’s portfolio of FDA cleared and patent protected technologies include NuStat® OTC, NuStat Trauma XR® and NuStat Flex XR®.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of healthcare by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

The Product Manager role creates, executes, and manages full-stream marketing efforts for the Hospital business. The incumbent will lead marketing efforts and actively partner with the Sales organization, customers and KOL development to ensure the execution and implementation of the marketing strategies.

Primary Duties & Responsibilities

  • Provide day to day management of assigned product line, programs and sales support in the field.
  • Create and manage programs to increase penetration and drive sales of existing products, sales and product promotions, customer targeting.
  • Develop product pipeline and roadmap to align with business unit strategic initiatives.
  • Develop content for core products and new product introductions including market development, training, education and sales/marketing collateral (publications, brochures, electronic media and marketing communication/education content).
  • Develop and/or consult on operational initiatives to improve cost, quality, product efficiencies, and profitability.
  • Create designated product line positioning and pricing strategy.
  • Support the Sales team with sales materials, customer communications and presentations, information for Request for Proposals (RFPs).
  • Profit and Loss responsibility for the hospital product line.
  • Collaborate with Demand Planning, Manufacturing, and Distribution to maintain high service levels.
  • Provide support, as needed, to the Regulatory Affairs team on local product registrations.
  • Attend tradeshow meetings and education workshops. Participate in sales training efforts at annual sales meetings and regional breakouts.

Knowledge, Skills and Abilities

  • Bachelor’s degree required with areas of preference including marketing, biomedical engineering, business administration or other similar degree area. Extensive related experience (e.g. Clinical) may be considered in lieu of a degree.
  • 3+ years marketing experience in overall product portfolio management with limited supervision.
  • Experience in regulated industry, specifically medical device preferred.
  • Comfort level in clinical environment (operating room, etc.). Demonstrated aptitude or prior experience with clinical terminology and general clinical practices is preferred.
  • Strong communication skills with the ability to present information clearly.
  • Proven ability to demonstrate practical application of successful marketing/business/portfolio management concepts and methodologies, as well as knowledge of measurement and analysis of commercial effectiveness.
  • Basic understanding of factors that impact product center’s profitable performance and competitive advantage (i.e. Revenue, Margin, ASP, Market Share Data, Pro-forma metrics, Market Definition)
  • Ability to drive focus, prioritization, and effective time/project management.
  • Proven ability to work with colleagues to drive consensus on product portfolio decisions.
  • Ability to work in a lean environment without large infrastructure.
  • Unquestionable ethics and integrity.

Employee Benefits

Beeken Biomedical values its employees and is working hard to become an employer of choice by offering competitive pay and benefits. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental, and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the Plan is fully paid by the Company.
  • Flexible Spending Accounts: Several Flexible Spending Plan options.

Regional Sales Director – East

Reports To: President/CEO

Company Overview

Beeken Biomedical, LLC is a medical device company focused on the development, licensing, and commercialization of hemostasis products in the acute, ambulatory, surgical and pre-hospital markets.  Beeken’s portfolio of FDA cleared and patent protected technologies include, NuStat® OTC, NuStat Trauma Pad® XR and NuStat Flex® XR.

Beeken Biomedical’s mission, and the focus of every employee, is to improve the quality of health care by designing, producing and marketing innovative, high-quality products. Our emphasis is on our customers’ satisfaction and sustained growth of shareholder equity. We strive to demonstrate thoughtful leadership, provide meaningful opportunities for employees and be a responsible member of the local communities in which we conduct business.

Beeken Biomedical is headquartered in Stoughton, MA.

The Regional Sales Director – East position for Beeken Biomedical is responsible for leading the Eastern Region hospital sales force consisting of 3-4 sales representatives, covering the Northeast U.S. As a key member of the Beeken Biomedical sales leadership team this position will develop and deploy the NuStat® portfolio of advanced hemostatic dressings sales strategy and tactics in support of profitable revenue growth.

Essential Duties & Responsibilities

  • Develop and oversee strategies and tactics that mobilize the Beeken Biomedical sales force to achieve the annual sales and gross profit dollar plan.
  • Develop and implement sales processes and metrics for increased productivity, profitable revenue growth, and customer satisfaction.
  • Collaborate with the Beeken Biomedical sales leadership team to develop quarterly and annual sales goals and objectives by product line and geographic territory.
  • Monitor and communicate progress against sales objectives through weekly, quarterly and annual sales plans. Make appropriate and timely decisions to ensure performance is tracking to or exceeding plans.
  • Re-evaluate sales tactics on an ongoing basis to ensure achievement of goals.
  • Administer sales compensation plan and determines annual sales quotas that align with annual operating plan.
  • Assess market, competitor, and supplier actions and collaborate with the marketing team to ensure appropriate and best in class product and services offering/messaging.
  • Develop and sustain relationships with key customers to stay abreast of current and emerging customer needs.
  • Build and sustain a world class regional sales team.
  • Is comfortable being a ‘player/coach’, actively selling alongside the regional sales representatives.
  • Take an active role in developing direct reports through individual performance feedback, team meetings, stretch assignments, regional sales meetings and national sales meetings.
  • Empower self and others through effective, collaborative relationships that accomplish sales objectives and create an open and supportive work environment.
  • Ensure sales team is equipped with the tools and resources to drive profitable revenue growth.
  • Is a participative member of the sales leadership team.

Knowledge, Skills and Abilities

  • Minimum 3-5 years’ sales management experience with a proven track record of leading high performing sales teams.
  • Minimum five years’ experience in Medical Device and or Medical Device Distribution industries.
  • Strong Operational Room sales background, preferably within the Trauma services space.
  • Strong business acumen with ability to plan and forecast sales on a regional and product category level.
  • Strong leadership capabilities with proven track record of building and sustaining high performing sales teams.
  • Ability to develop compensation plans that drive field sales productivity and sustained revenue growth.
  • Strategic mind set with ability to lead sales teams and solve day-to-day issues.
  • Advanced planning capabilities coupled with exceptional financial and analytical skills.
  • Impeccable interpersonal skills appropriate for both audience and selling situations.
  • Strong negotiation skills with a record of favorable outcomes that are mutually advantageous to the company and the customer.

Employee Benefits and Compensation

Beeken Biomedical values its employees and is working hard to become an employer of choice by offering competitive pay and benefits. Some of the many benefits we offer include:

  • Healthcare Plan: including prescription drug coverage, dental and vision.
  • Paid holidays and vacation.
  • Retirement Savings Plan (401k)
  • Short/Long Term Disability: The cost of the plan is fully paid by the company
  • Flexible Spending Accounts: Several Flexible Spending Plan options
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