Quality Assurance Leader, Medical Devices & Compliance

Regulatory Jobs; Pennsylvania; On-site; USD 124,000 - 212,000; Full time

Benefits offered by this job

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off

3–5 weeks paid vacation (hourly)

Paid sick time (up to 64 hours)

Job summary

Haemonetics is hiring a Senior Manager, Quality Assurance for the Center of Excellence in Clinton, PA. This role leads the Quality Systems and compliance programs across the plant, ensuring adherence to MDR, ISO 13485, CMDR, and QSRs. Collaboration with management drives CAPA, audits, and continuous improvement.

The ideal candidate has 8+ years in QA within regulated industries, 5+ years of leadership, and expertise in regulatory requirements, with a strong manufacturing operations background.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related technical discipline.
• 8+ years of progressive QA or Quality Systems experience within a regulated industry.
• 5+ years of leadership experience managing quality teams.
• Experience with FDA regulations, ISO 13485, MDR/IVDR preferred.
• Medical device, biotech, pharma, or combination product experience.
• Experience supporting manufacturing operations and quality system compliance.
• Experience leading multiple quality functions (CAPA, Audits, Design Assurance, Validation, Supplier Quality).
• Six Sigma Green/Black Belt or ASQ certification preferred.

Responsibilities

• Define short- and long-term QA strategy for the site and corporation.
• Lead implementation and continuous improvement of the Quality Management System.
• Serve as SME for the Haemonetics Quality Management System.
• Promote awareness of regulatory and customer requirements.
• Oversee internal audits, management reviews, KPI monitoring and trend analysis.
• Collaborate with Plant Management on design changes and quality planning.
• Identify and resolve quality issues; integrate requirements into processes.
• Initiate and monitor CAPAs for timely resolution and compliance.
• Represent Haemonetics in 2nd- and 3rd-party audits and inspections.
• Oversee incoming, in-process, and finished goods inspections.
• Develop and mentor Quality team members.

Skills

Leadership

Regulatory knowledge

Quality Systems

CAPA management

Audits

Manufacturing support

Education

Bachelor's degree in Engineering, Life Sciences, Quality or related

Advanced degree preferred (MS, MBA)

Tools

ASQ certification

Job description

Haemonetics is hiring a Senior Manager, Quality Assurance for the Center of Excellence in Clinton, PA. This role leads the Quality Systems and compliance programs across the plant, ensuring adherence to MDR, ISO 13485, CMDR, and QSRs. Collaboration with management drives CAPA, audits, and continuous improvement.

The ideal candidate has 8+ years in QA within regulated industries, 5+ years of leadership, and expertise in regulatory requirements, with a strong manufacturing operations background.