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Quality Manager - Medical Device / ISO 13485
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Job Description
Quality Manager - Medical Device / ISO 13485 at Talent Groups Quality Manager - Medical Device / ISO 13485 at Talent Groups in Burnham, Pennsylvania Posted in 1 day ago.
Type:
full-time 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 .
Must-Have 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
Preferred:
Bachelor's/Master's degree in Engineering or related field
ISO 13485
Lead Auditor certification ASQ/CQI certification Experience leading major quality remediation initiatives