Quality Engineer, CAPA & QMS Leader

Getinge; Wayne (NJ); On-site; USD 125,000 - 148,000; Full time

Job summary

Getinge in Wayne, NJ seeks a Staff Quality Engineer – CAPA & Compliance to lead complex CAPAs and oversee QMS documentation and audits. This role requires advanced technical leadership to ensure regulatory compliance and sustainable quality improvements.

The position is based at the Wayne, NJ headquarters four days a week, with collaboration across cross-functional teams to drive CAPA performance, risk assessments, and process improvements within the Cardiac Assist business.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, or related technical discipline.
• Minimum of eight years in quality assurance/engineering with CAPA and medical-device QMS.
• Experience with complex investigations, root-cause analysis, CAPA effectiveness and audits.
• Advanced knowledge of FDA QSR, ISO 13485, ISO 14971, MDSAP, and EU requirements.
• ASQ certification or equivalent strongly preferred.

Responsibilities

• Lead complex CAPAs from initiation through effectiveness verification and closure.
• Perform root-cause analysis and risk assessment with appropriate quality methods.
• Coach CAPA owners and investigators in CAPA processes and systems.
• Develop and monitor QMS documentation and compliance activities.
• Participate in audits and remediation activities including internal and external audits.

Skills

CAPA leadership

QMS knowledge

Root-cause analysis

Audits

Education

Bachelor's degree in Engineering, Science, Quality, or related technical discipline

Job description

Getinge in Wayne, NJ seeks a Staff Quality Engineer – CAPA & Compliance to lead complex CAPAs and oversee QMS documentation and audits. This role requires advanced technical leadership to ensure regulatory compliance and sustainable quality improvements.

The position is based at the Wayne, NJ headquarters four days a week, with collaboration across cross-functional teams to drive CAPA performance, risk assessments, and process improvements within the Cardiac Assist business.