Boston Microfluidics is seeking a Quality Engineer to join our product development team. Reporting to the QA Manager, the Quality Engineer will leverage their experience and working knowledge of quality systems, new product development, supplier controls, inventory controls, and subcontractor management to play a key hands-on role in developing and launching new products that are of the highest quality and compliant to medical device regulations. The candidate will engage with every aspect of an ISO 13485 quality system. Boston Microfluidics offers the candidate the opportunity to learn hands-on by working directly with the QA Manager, as well as the Manufacturing and Product Development teams. This is an exciting opportunity to help lead our design verification and validation efforts.

Responsibilities:

• Participate as a member of the quality team to assure that the company’s quality management system is in ongoing compliance with applicable standards and regulations, including 21 CFR Part 820 and ISO 13485:2016.
• Investigate and process all customer complaints for post-launch products according to Complaint Handling SOP.
• Maintain all equipment, calibration, and inventory control according to relevant SOPs, as applicable.
• Originate NCRs, CAPAs, SCARs, Deviations, and Change Orders as necessary.
• Support Risk Assessment activities, including: Failure Mode and Effects Analyses, Hazard Analysis, Post-Market Surveillance, and Risk Management Plans and Reports.
• Support BMF’s Supplier Management system.  Ensure that suppliers are qualified, as required.  Develop, implement and manage processes for transferring product designs to manufacturing at external suppliers and tracking supplier performance.
• Provide quality engineering expertise in projects to develop medical devices.  Create and help manage the content of DHFs, including design reviews, and ensure that products meet performance specifications, regulatory and manufacturing requirements.
• Participate in Product verification/validation activities, including the development of protocols, work instructions, and acceptance criteria for raw materials, components and final devices.
• Support Internal Quality Audits, External Audits, and Vendor Audits.
• Conduct employee and contractor training, as appropriate, to guide and develop personnel in areas of subject matter required for employees’ specific roles.
• Support the creation and execution of the Annual Quality Plan and the Management Review Board Presentation.  Contribute to the development and implementation of metrics for Management Review Meetings, as appropriate.
• Perform system management and document control activities, as needed
• Communicating, brainstorming and collaborating with a diverse, close-knit team

Education:

• Bachelor's degree in Engineering or relevant life science.
• 10 - 20 years of quality engineering experience in the medical device, pharmaceutical, or biotech industry.
• Lead ISO 13485 Auditor Training Certification desired.

Skills:

• Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation, Supplier Controls, and Risk Management.
• Proficiency with commonly used computer software such as Excel, Word, PowerPoint, etc.
• Ability to travel (estimated at 20% of time).

Knowledge:

•  Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation; Design Control; Supplier Control; ISO 13485; and ISO 14971.

Benefits:

• Competitive pay, stock options, and annual bonus eligibility
• Option to participate in company medical, dental, and vision plans
• Commuter benefits
• Conveniently located close to the Alewife MBTA station
• Company-paid parking spot
• Weekly catered lunch
• 401(k) retirement plan options
• Ongoing professional development
• Secure / Covered Bike Storage Facility
• Office park amenities such as a fitness center, community events, outdoor recreation events, Pop-up Shops, and Tenant Appreciation Events