Quality Systems Engineer: CAPA & Process Excellence

Haemonetics Interventional Technologies; Pennsylvania; Vor Ort; USD 68.000 - 116.000; Vollzeit

Benefits dieser Stelle

401(k) with match

Employee stock purchase plan

Flexible time off

Paid vacation

Paid sick time

Holidays

Parental leave

Disability insurance

Tuition reimbursement

Health benefits

Zusammenfassung

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.

Responsibilities include developing and coordinating quality systems and procedures, investigating CAPA and non-conformances, supporting QC holds, and ensuring qualifications

Qualifikationen

• 3–5+ years of work experience in a related function is required.
• Professional experience with Statistical Process Control.
• Computer knowledge and experience with Microsoft Office and document management systems (e.g., Agile).

Aufgaben

• Develop and coordinate implementation of quality systems, procedures, test methods, problem definitions and resolutions for existing and new products in compliance with QMS.
• Investigate CAPA, non-conformances, defects, and process failures to identify areas for improvement and drive resolution.
• Support QC Hold process by providing QA input and communicating hold information to stakeholders.
• Assist in manufacturing quality systems and customer quality requirements.
• Support product improvement projects (IQ/OQ/PQ) and supplier changes to ensure qualifications are met.
• Lead or participate in teams related to complaint investigations, CAPA, cost reduction, design changes, and quality system excellence.
• Conduct risk analyses as needed.
• Develop, review and challenge existing quality-driven test systems and procedures.
• Maintain records to ensure GMP/regulatory compliance.
• Monitor internal and external quality levels to trigger improvements.

Kenntnisse

Statistical Process Control

Quality improvement

Problem solving

Documentation

Ausbildung

Bachelor's Degree in Engineering or Life Science

Tools

Microsoft Office

Agile

Document management systems

Jobbeschreibung

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.

Responsibilities include developing and coordinating quality systems and procedures, investigating CAPA and non-conformances, supporting QC holds, and ensuring qualifications