Quality Systems Engineer: CAPA & Compliance Lead

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

Benefits offered by this job

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off

Vacation and holidays

Paid sick time

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

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

You will develop and implement quality systems, investigate CAPA and non-conformances, support QC hold processes, and collaborate with R&D, Manufacturing, Supply Chain, and

Qualifications

• Bachelor's degree in engineering or life sciences.
• 3–5+ years of relevant work experience.
• Experience with Statistical Process Control.
• Proficiency with Microsoft Office and document management systems (e.g., Agile).

Responsibilities

• Develop and implement quality systems, procedures, and test methods per QMS.
• Investigate CAPA, non-conformances and defects; lead resolutions.
• Support QC hold process and communicate findings to stakeholders.
• Assist in manufacturing quality systems and supplier changes.
• Lead or participate in projects related to complaint investigation and quality system excellence.
• Conduct risk analysis and support quality improvement initiatives.
• Collaborate with multiple departments to provide quality guidance.
• Maintain GMP/regulatory records and monitor product quality.

Skills

Statistical Process Control

Microsoft Office

Agile

Education

Bachelor's degree in Engineering or Life Science

Tools

Agile

Job description

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

You will develop and implement quality systems, investigate CAPA and non-conformances, support QC hold processes, and collaborate with R&D, Manufacturing, Supply Chain, and