Quality Manager – Medical Device / ISO 13485

Talent Groups; Reedsville (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Talent Groups in PA seeks an experienced Medical Device Quality Manager to lead QMS, remediation, CAPA, audits, and regulatory compliance programs. You will work with cross-functional teams to ensure compliance with FDA, ISO 13485, and global medical device regulations.

The role requires 12+ years in medical device quality and 5+ years of leadership, with strong expertise in CAPA, risk management, and inspections. On-site, full-time, in Pennsylvania.

Qualifications

• 12+ years of medical device quality experience.
• 5+ years leading quality management teams.
• 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.
• Remediation, compliance programs, metrics, and management reviews.
• Experience supporting FDA inspections and regulatory audits.
• Proven cross-functional leadership and problem-solving skills.

Skills

Medical Device Quality

Quality Leadership

QMS & CAPA

Regulatory Knowledge

Risk Management

Design Controls

Remediation & Compliance

FDA Inspections

Cross-functional Leadership

Problem-Solving

Education

Engineering Degree

ASQ / CQI Certification

Job description

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
• ASQ/CQI certification
• Experience leading major quality remediation initiatives