Principal Quality Engineer (Design Assurance)

Waltham, MA

We are looking for a Principal Quality Engineer – Design Assurance Specialist who will assume a technical leadership role in the development of next generation medical devices that are positively disruptive and lifesaving in the pediatric, cardiac and respiratory arenas. This early stage company is hitting its stride very nicely, with an impressive investment team and partnerships with some of the most respected names in the industry.
In this role, you’ll apply your medical device design assurance expertise to ensure our client’s medical devices are safe, effective, and delivered to our customers on time. As a member of the QA/RA team you will provide design assurance support to product development; ensuring that the Quality Management System is being followed so that all design and development activity is fully compliant with global medical device regulations and standards.

You will be a key participant on the engineering and manufacturing teams to ensure that the appropriate documentation (DHF, Design Dossier, Technical File, etc.) is generated.

Responsibilities

• Work closely with new product development teams and other appropriate departments to develop quality plans, contribute to design reviews and risk management as well as provide guidance to ensure that design and other documentation is consistent and compliant to regulations, and is appropriate for the DHF and Technical files.
• Participate in medical device hardware and software Design and Development Team meetings and activities as a member of the Team.
• Provide guidance in the interpretation of global regulations and standards.
• Create applicable design and development deliverables associated with the Design Assurance Quality Engineering function.
• Review all Design and Development deliverables to ensure compliance with the Product Development Plan, QMS and applicable regulations and standards.
• Provide leadership and understanding for Risk Management activities, ensuring Risk Management Files are kept up to date.
• Assure all applicable quality decisions utilize risk management documentation as appropriate.
• Provide leadership, guidance and approval to V&V planning and related activities including suppliers as required
• Support Internal audits as a qualified auditor/lead auditor.
• Participate in change assessment activities through to Design Transfer and product launch.
• Participate in medical device software issue management activities throughout the product lifecycle.

Requirements

• Bachelor’s degree in life science or engineering.
• Minimum 5 years of medical device design assurance experience with medical device design and submissions for FDA Class II or III medical devices.
• Experience reviewing mechanical, software and electronics design requirements and specifications and working knowledge of medical device design controls
• Hands-on experience with medical device hardware and software lifecycle processes and risk management including verification and validation activities
• Working knowledge of FDA 21 CFR 820 and the EEC MDD/MDR.
• Proficiency with MS Office (Word/Excel/PowerPoint) and familiarity with PLM and QMS software tools.
• Excellent documentation skills including record maintenance/tracking and an understanding of document traceability.

Inquiries and resumes to:

Kathy Provost at kathy@agilesearchinc.com or 978/952-6425

Dec, 06, 2019

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