QA Engineer - Medical Device Compliance & Quality Systems

Onkos Surgical; Parsippany-Troy Hills (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Onkos Surgical is seeking a QA Engineer to help implement the Quality Management System and ensure regulatory compliance for medical devices, supporting complaint handling, product release, NCR and CAPA processes, and collaboration with suppliers and cross-functional teams.

The role focuses on developing technical files for regulatory compliance during product development and ensuring adherence to CFR Part 820 and ISO 13485.

Qualifications

• Minimum of 3 years QA experience in medical device industry.
• Working knowledge of CFR Part 820 and ISO 13485.
• Complaint investigation experience.
• BS in an engineering discipline.
• Certified Quality Engineer certification a plus.
• Experience in root cause failure analysis and change control.
• Detail oriented with manufacturing environment experience a plus.
• Good verbal and written communication skills.

Responsibilities

• Receive, document and process complaints related to product quality and patient safety.
• Conduct, coordinate and document complaint investigations.
• Review complaints for possible Adverse Events/MDRs and regulatory reporting decisions.
• Review and approve Device History Records (DHRs) and communicate with suppliers to ensure compliance.
• Participate in and support NCR and CAPA investigations.
• Apply statistical methods to trend NCRs, CAPAs, complaints, and DHRs.
• Support supplier vetting and maintaining Approved Supplier List.
• Provide quality engineering support on design transfer and process validations.
• Participate in risk assessment efforts, including FMEA.
• Monitor quality metrics and drive quality improvements.
• Lead or participate in cross‑department initiatives to improve quality and ensure QMS compliance.

Skills

Quality Assurance

Medical devices

CFR Part 820 knowledge

13485 knowledge

Root cause analysis

Change control

Documentation skills

Communication skills

Education

BS in Engineering

Tools

FMEA

CAPA

DHR review tooling

Job description

Onkos Surgical is seeking a QA Engineer to help implement the Quality Management System and ensure regulatory compliance for medical devices, supporting complaint handling, product release, NCR and CAPA processes, and collaboration with suppliers and cross-functional teams.

The role focuses on developing technical files for regulatory compliance during product development and ensuring adherence to CFR Part 820 and ISO 13485.