Quality Systems Engineer: CAPA & Compliance

haemonetics; Pennsylvania; On-site; USD 68,000 - 116,000; Full time

Benefits offered by this job

401(k) with up to 6% employer match

Health and welfare benefits

Flexible time off

Job summary

Haemonetics is seeking a Quality Systems Engineer to support its Center of Excellence in Clinton, PA. The role drives quality improvements through investigations, CAPA ownership, risk analysis, and cross-functional problem-solving to ensure regulatory compliance.

Responsibilities include developing quality systems, coordinating CAPA investigations, supporting QC Holds, and driving improvements with cross-functional teams. Experience with GMP and document management is required.

Qualifications

• Bachelor's Degree in Engineering or Life Science.
• 3-5+ years of related work experience required.
• Experience with Statistical Process Control.
• Experience with Microsoft Office and document management systems.

Responsibilities

• Develop and coordinate quality systems and procedures in compliance with QMS.
• Investigate CAPA, non-conformances, defects, and process failures for improvements.
• Support QC Hold processes, provide QA input, and communicate hold information.
• Assist in manufacturing quality systems and supplier changes to meet qualifications.
• Lead or participate in projects related to complaints, CAPA, and quality system excellence.
• Conduct risk analyses as needed and review quality-driven test procedures.
• Maintain GMP/regulatory records and monitor quality levels for improvements.
• Collaborate with Customer Service, Supply Chain, Sales, Marketing, Legal, Manufacturing and R&D.

Skills

Statistical Process Control

Microsoft Office

Agile

Education

Bachelor's Degree in Engineering or Life Science

Tools

Microsoft Office

Job description

Haemonetics is seeking a Quality Systems Engineer to support its Center of Excellence in Clinton, PA. The role drives quality improvements through investigations, CAPA ownership, risk analysis, and cross-functional problem-solving to ensure regulatory compliance.

Responsibilities include developing quality systems, coordinating CAPA investigations, supporting QC Holds, and driving improvements with cross-functional teams. Experience with GMP and document management is required.