Senior Quality Assurance Lead: CAPA & Compliance

Getinge; Merrimack (NH); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge is seeking a Principal Quality Assurance professional to provide high-level CAPA oversight within the Quality Compliance department. You will mentor cross-functional teams, drive investigations, and ensure timely CAPA closure while maintaining ISO 13485 and FDA/regulatory compliance.

In this hybrid role, you will guide project teams, document outcomes, and support external audits. A Bachelor's or Master’s in engineering or science with 8+ years in regulated industries is required, along

Qualifications

• Bachelor's or Master's degree in engineering or science, or equivalent.
• Minimum 8 years' experience in medical device or highly regulated industry.
• Expertise in CAPA systems and root cause analysis.
• Ability to lead cross‑functional project teams and manage timelines.
• Strong problem‑solving, communication, and organizational skills.

Responsibilities

• Provide principal CAPA oversight and guide cross‑functional teams.
• Lead investigations, root cause analyses, and CAPA verifications.
• Support QMS activities and regulatory compliance, including audits.

Skills

CAPA systems

Root cause analysis

Cross-functional leadership

Project management

Problem solving

Quality system knowledge

Regulatory knowledge (FDA/ISO)

Education

Bachelor's or Master's in Engineering/Science

Tools

MS Office

Statistical software

Job description

Getinge is seeking a Principal Quality Assurance professional to provide high-level CAPA oversight within the Quality Compliance department. You will mentor cross-functional teams, drive investigations, and ensure timely CAPA closure while maintaining ISO 13485 and FDA/regulatory compliance.

In this hybrid role, you will guide project teams, document outcomes, and support external audits. A Bachelor's or Master’s in engineering or science with 8+ years in regulated industries is required, along