Senior R&D CAPA Engineer - Hybrid, Impactful Quality Work

Getinge Group; Wayne (NJ); Hybrid; USD 115,000 - 140,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Parental and Caregiver Leave

Tuition Reimbursement

Job summary

Getinge in Wayne, NJ is seeking a Senior R&D Engineer – CAPA Specialist to lead complex CAPA investigations within R&D. The role emphasizes root cause analysis, corrective/preventive actions, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement.

Operating with autonomy, you will act as a technical authority, guiding CAPA practices while mentoring engineers.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 5+ years of experience in R&D engineering within a medical device organization.
• Experience managing CAPA activities within product design and development.
• Strong understanding of FDA regulations and ISO 13485.

Responsibilities

• Lead CAPA investigations from problem definition through verification.
• Perform root cause analyses for design and product issues.
• Develop robust corrective and preventive actions that are risk-based and technically sound.
• Ensure CAPA documentation is accurate and compliant with regulatory requirements.
• Collaborate with Quality, Regulatory Affairs, Operations, and Manufacturing Engineering.

Skills

CAPA methodologies

Root cause analysis

Regulatory knowledge

Problem solving

Education

Bachelor’s degree in Engineering

Tools

TrackWise

Job description

Getinge in Wayne, NJ is seeking a Senior R&D Engineer – CAPA Specialist to lead complex CAPA investigations within R&D. The role emphasizes root cause analysis, corrective/preventive actions, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement.

Operating with autonomy, you will act as a technical authority, guiding CAPA practices while mentoring engineers.