Quality Manager – Medical Device/ISO
Job in
Reedsville, Mifflin County, Pennsylvania, 17084, USA
Listed on 2026-10-06
Listing for:
Talent Groups
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Location: Reedsville
Seeking an experienced Medical Device Quality Manager to lead QMS, remediation, CAPA, audit readiness, and regulatory compliance programs. The role will work closely with cross-functional teams to ensure compliance with FDA, ISO 13485, and global medical device regulations
.
Skills:
- 12+ years of Medical Device Quality experience
- 5+ years of Quality Management / leadership experience
- Strong expertise in QMS, CAPA, Nonconformance, Complaints, and Audits
- Strong knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485
- Experience with Risk Management and Design Controls
- Quality remediation, compliance programs, metrics, and Management Reviews
- Experience supporting FDA inspections and regulatory audits
- Strong cross-functional leadership and problem-solving skills
- Bachelor’s/Master’s degree in Engineering or related field
- ASQ/CQI certification
- Experience leading major quality remediation initiatives
For the Quality Manager – Medical Device / ISO 13485 position at Talent Groups, we are reviewing applications now.
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