Key Responsibilities

• Design and Development Support:
• Act as the primary quality representative during design and development activities.
• Ensure compliance with applicable standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Participate in risk management activities, including conducting and reviewing DFMEA/PFMEA.
• Regulatory Compliance:
• Ensure adherence to Design Controls, including documentation of Design History Files.
• Support regulatory submissions by providing necessary quality documentation.
• Interpret and apply relevant global standards and regulations to product design.
• Verification and Validation (V&V):
• Develop and execute test plans and protocols for design verification and validation.
• Review and approve V&V documentation to ensure product meets design specifications.
• Quality Assurance:
• Lead or support root cause analysis and corrective/preventive actions (CAPA) for design-related issues.
• Review and approve engineering change orders (ECOs) and design changes.
• Collaborate on supplier quality management as it relates to design inputs and outputs.
• Continuous Improvement:
• Promote quality best practices within the engineering and product development teams.
• Identify and implement process improvements to enhance product quality and efficiency.

Qualifications

Education:

• Bachelors Degree in a relevant field - ideally BSME (Mechanical, Biomedical, Electrical are all acceptable).
• Advanced degree or certification (CQE, CRE, or equivalent) is a plus.

Experience:

• 3-5 years of experience in quality engineering within the medical device industry.
• Strong understanding of design controls and regulatory requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR).
• Experience with risk management standards (ISO 14971) and validation methodologies.