Senior Design Quality Assurance Engineer

Senior Design Quality Assurance Engineer

Vacancy expired!

Job Summary:
Senior Design Assurance Engineers maintain an effective quality system, including compliance with FDA Design Controls and ISO 13485 requirements to support product clearance/approvals/licenses, and qualification of quality systems. Senior Design Assurance Engineers work with design teams to ensure that devices are designed in accordance with the product requirements, and that they meet their intended use. They review requirements, specifications, and technical design documents to provide timely and meaningful feedback aimed at improving product quality, safety, reliability, and manufacturability, and ultimately ensure customer satisfaction.

Senior Design Assurance Engineers have extensive/broad knowledge, use creativity to solve complex issues, and contribute to project planning. They have demonstrated leadership and communication skills that contribute to customer confidence and satisfaction. Additionally, they may supervise a team of engineers and technicians.


Job Duties and Responsibilities:

• Monitor project activities to ensure teams follow Minnetronix Standard Operating Procedures and Best Practices.


• Manages project risk management and oversees compliance to ISO 14971, which includes creation of project risk management plans and reports


• Audits software development process against the IEC 62304 standard and FDA guidance


• Audit test execution management, device testing, dry run status, development build process, and Safety/EMC Test Reports


• Ensuring verification configurations tested are production equivalent.


• Review/Approve regression analyses, trace matrices, engineering change orders, development device build records, development and verification tool qualifications, and verification test procedures


• Participates/Approves in development of requirements, technical reviews, test report development, design transfer coordination/support and PFMEA, DFMEA development


• Participates in project/customer meetings and Phase Reviews


• Mentor junior engineers in quality practices


• Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.

• Bachelor's Degree/Technical Degree in Engineering or equivalent experience


• 4-8 years' experience in a Medical Device manufacturing/product development environment


• Working knowledge of FDA QSRs, ISO 13485, and ISO 14971 requirements


• Experience/knowledge with product/process verifications/validations


• Experience with DFMEAs, PFMEAs and Risk Management


• Must possess good project management skills and initiative in taking on and completing projects


• Must possess good verbal and written communication skills


• Must be able to manage and prioritize multiple projects/objectives


• Strong interpersonal, teamwork, and communication skills.


• Strong written communication demonstrating the ability to simplify complex information.