Hybrid Quality & CAPA Engineer II

Getinge; Merrimack (NH); Hybrid; USD 90,000 - 110,000; Full time

Job summary

Getinge is seeking a CAPA Coordinator to provide Quality Assurance support for CAPA activities and related QMS initiatives. The role focuses on leading CAPA requests, driving investigations, and ensuring timely closures in a highly regulated medical device environment.

The position requires a engineering or science background, 2+ years in quality roles, and strong knowledge of CAPA, NCR, and process controls. Hybrid work arrangement is offered, with responsibilities across cross-functional teams.

Qualifications

• Bachelor’s degree in engineering or scientific discipline or equivalent experience.
• 2+ years’ quality experience in medical device or highly regulated industry.
• Experience performing root cause investigations.

Responsibilities

• Lead CAPA requests and teams through CAPA processes to ensure timely completion.
• Provide project management support to CAPA activities and timelines.
• Review CAPA documentation for compliance with procedures and regulations.
• Drive problem definition, root cause analyses, and scoping of CAPAs.
• Facilitate investigations and develop effectiveness check criteria.
• Perform VOI/VOE and document CAPA activities in electronic systems.
• Communicate reminders and provide CAPA training as needed.
• Prepare documentation for trending and metrics using Microsoft Office.
• Support the Quality Compliance department and internal/external audits.

Skills

Root cause analysis

CAPA

Project management

Communication

Data analysis

Quality systems ISO 13485

Education

Bachelor's degree in engineering or sciences

Tools

Microsoft Office

Job description

Getinge is seeking a CAPA Coordinator to provide Quality Assurance support for CAPA activities and related QMS initiatives. The role focuses on leading CAPA requests, driving investigations, and ensuring timely closures in a highly regulated medical device environment.

The position requires a engineering or science background, 2+ years in quality roles, and strong knowledge of CAPA, NCR, and process controls. Hybrid work arrangement is offered, with responsibilities across cross-functional teams.