Quality Engineer
Job Location:
Job Location:
Marlborough, NH - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
5 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: Quality Engineer Medical Devices
Location: Marlborough MA or Newark DE
Contract: 06months
Job Summary:
Seeking a Quality Engineer with medical device industry experience to support quality systems compliance validation and continuous improvement activities in a regulated manufacturing environment.
Roles & Responsibilities:
- Ensure compliance with FDA ISO 13485 GMP and company quality standards.
- Investigate non-conformances deviations and customer complaints; support CAPA activities.
- Participate in risk assessments FMEA and root cause analysis.
- Support process validation (IQ/OQ/PQ) and equipment qualification activities.
- Review and approve quality documentation procedures and engineering changes.
- Collaborate with Manufacturing Engineering and Supplier Quality teams to resolve quality issues.
- Conduct internal audits and support regulatory inspections.
- Analyze quality metrics and drive continuous improvement initiatives.
Required Skills:
- Medical Device Quality Engineering
- ISO 13485 & FDA 21 CFR Part 820
- CAPA NCR and Root Cause Analysis
- FMEA / Risk Management
- IQ/OQ/PQ Validation
- GMP Compliance
- Internal Audits and Documentation Control
