Hybrid Staff Quality Engineer – CAPA & QMS Leader

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

Job summary

Getinge in Wayne, NJ is seeking a Staff Quality Engineer – CAPA & Compliance to lead complex CAPA investigations and ensure QMS compliance. The role concentrates on CAPA governance, process improvement, audits, documentation, and cross-functional collaboration to drive sustained quality across the Cardiac Assist business.

You will work at the Wayne headquarters four days a week, mentor CAPA owners, and partner with regulatory affairs, Manufacturing, and R&D to harmonize procedures and enhance

Qualifications

• Bachelor's degree in Engineering, Science, Quality or related field.
• 8+ years in quality assurance/quality engineering or CAPA in regulated industry.
• Experience with medical-device QMS and regulatory requirements is required.

Responsibilities

• Lead complex CAPAs from initiation through verification and closure.
• Coach CAPA owners and investigators in QMS processes and tools.
• Drive CAPA effectiveness verification, trend analysis, and governance reviews.
• Improve documentation, controls, and cross-functional remediation.

Skills

CAPA leadership

Quality leadership

Root-cause analysis

Audits

Problem solving

Education

Bachelor's degree in Engineering/Science/Quality

Master's degree preferred

Tools

TrackWise

Minitab

Microsoft Office

Job description

Getinge in Wayne, NJ is seeking a Staff Quality Engineer – CAPA & Compliance to lead complex CAPA investigations and ensure QMS compliance. The role concentrates on CAPA governance, process improvement, audits, documentation, and cross-functional collaboration to drive sustained quality across the Cardiac Assist business.

You will work at the Wayne headquarters four days a week, mentor CAPA owners, and partner with regulatory affairs, Manufacturing, and R&D to harmonize procedures and enhance