What are the responsibilities and job description for the Senior Quality Engineer position at MCRA, an IQVIA business?
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.
MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Sr. Quality Engineer.
Summary
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.
Duties and Responsibilities
Quality Engineering – Post Market & Manufacturing Support
- 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.
Quality Engineering – New Product Development
- 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.
Quality Systems
- Support complaint processing, recalls, supplier quality, CAPA, audits, and management reviews.
- Assist with regulatory inspections and EU MDR transition.
Education & Experience:
- 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; SolidWorks preferred.
Special Requirements:
- Onsite