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Our Boston area client is adding to their staff a highly-motivated Quality Engineer who wants to make an impact in the healthcare industry with groundbreaking technology. This is for the person who has an aptitude for technology, exceptional communication and training skills who is excited for the opportunity to support the introduction of an innovative, lifesaving technology in the field of transfusion medicine.
Responsibilities
- Ensure QMS compliance with ISO 13485, EU MDR, MDSAP, and 21 CFR 820.
- Provide product quality oversight, including review of batch records, test results, nonconformances, MRB activities, and product release decisions.
- Monitor product quality metrics and support investigations, root cause analysis, and effective CAPA implementation.
- Support design controls, risk management (ISO 14971), process validation, and quality review of engineering change orders.
- Participate in internal audits, external audits, and regulatory inspections.
- Collaborate with manufacturing, engineering, and suppliers to resolve product or process quality issues.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 2–5+ years of medical device quality engineering or QMS experience.
- Strong working knowledge of ISO 13485, EU MDR, MDSAP, and 21 CFR 820.
- Experience with CAPA, nonconformance management, risk management, and product quality oversight.
- Strong analytical, communication, and problem-solving skills.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Quality Assurance, Engineering, and Design
- Medical Equipment Manufacturing