Senior Quality Engineer

Notice: MCRA’s Talent Solutions division works to untie top talent with opportunities on our clients’ teams.
This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

Responsible for ensuring product quality and safety for both new product development and existing products. Applies engineering and statistical techniques to support design, manufacturing, and post-market activities. Manages multiple projects and collaborates across teams to meet quality objectives and regulatory requirements.

• Investigate product complaints, manage returns, and perform root cause analysis.
• Track and report post-market data and update risk management files.
• Execute CAPA investigations and corrective actions.
• Maintain supplier quality through evaluations and audits.
• Ensure compliance with FDA, ISO 13485, MDD, and MDR standards.
• Support manufacturing changes, non-conformance reports, and device history reviews.
• Maintain sterilization validations and microbiological control programs.

• Serve as Quality representative on development teams.
• Ensure new products meet regulatory and quality standards.
• Develop inspection and quality plans; provide statistical guidance.
• Collaborate with Engineering on design reviews, verification/validation testing, and risk management (FMEAs).
• Support process capability, equipment qualification, and validation activities.

• Support complaint processing, recalls, supplier quality, CAPA, audits, and management reviews.
• Assist with regulatory inspections and EU MDR transition.

• Bachelor’s in Engineering (preferred) or Natural Science.
• 4–10 years in medical device quality or engineering (or 2 years with advanced degree).
• Complaint investigation experience preferred.
• Strong knowledge of validation, root cause analysis, CAPA, and ISO 14971.
• Adaptable, organized, and effective in fast-paced environments.
• Proficient in MS Office;
  Solid Works preferred.

• Onsite