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
