Be a part of the Quality team at our Healthcare Optics Research Laboratory and see your work have a strong impact on bringing innovative Medical Devices to market. Work in a growing organization with a diverse group of people and in collaboration with world’s leading medical institutions. We are seeking an experienced Medical Device Quality Assurance Principal Engineer (Principal Engineer, Qty Assur) who can lead design assurance and risk management as a Core Team member and drive Quality System compliance.
- Provide leadership on Quality and Risk Management processes, which may include Design Assurance, CAPA, Supplier Management, etc. Participate in creating and implementing quality system processes. Coordinate and support activities related to implementing new or revised regulations and standards
- As a Quality Core Team member, takes full responsibility of ensuring that all design control activities including design inputs, design and development planning, design reviews, design verification and validation, and design transfer efforts are complaint and meet FDA’s expectations. Review and approve design control and product documentation
- Provide mentorship or supervise less experienced Quality personnel performing Design Verification and Validation or other Quality activities
- Ensures product safety by driving risk management activities including authoring risk management plans, interfacing with Medical Affairs, and facilitating and mentoring engineers on system risk assessments and FMEAs
- Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other qualification and acceptance testing
- Support the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation
- Participate in supplier management efforts for evaluating and approving key suppliers and developing quality agreements with consultants and contract manufacturers
- May plan and execute internal audits against applicable quality system standards, regulations and internal requirements. May support external audits
- Support the development of safe and effective Medical Devices in compliance with international Regulations
- Ensure the integrity of the Design History Files
- Ensure effective design transfers to Contract Manufacturing partners, along with Operations
- Support and facilitate successful completion of the Risk Management activities in New Product Development Projects.
- Education: BS or higher degree in engineering, or similar
- Experience: 8 years minimum Medical Devices Device experience with a minimum of 5 years of Quality experience with responsibility for design control and risk management processes and/or multiple other Quality System processes (e.g., CAPA, Supplier Management)
- Strong statistical background with experience in Minitab, JMP or similar statistical package
- Ability to apply knowledge of the requirements of FDA QSRs, ISO 13485 and ISO 14971 to a wide range of processes and issues
- Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus
The company will not pursue or support visa sponsorship for this position.