Quality Assurance Engineer

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

Job Summary

The Quality Assurance (QA) Engineer will play a key role in the implementation of Onkos Surgical’s Quality Management System and have the opportunity to gain experience across a broad range of quality functions related ISO 13485 and 21 CFR Part 820 compliance. Specifically, the QA Engineer will champion complaint handling, product release procedures and approval, and support to both NCR and CAPA processes. This will require developing relationships and working closely with suppliers. This position will also work with cross-functional teams to provide quality engineering support in the development of technical files to ensure regulatory compliance during product development.

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 recommend regulatory reporting decisions. Prepare reports to regulatory agencies in a timely manner to meet regulatory deadlines.
• Review and approve Device History Records (DHRs) and communicate closely with contract suppliers to ensure compliance with Quality Agreements and QMS procedures.
• Participate in and support NCR and CAPA investigations.
• Participate in the application of statistical methods to trend NCRs, CAPAs, Complaints, and DHR approval acceptance.
• Support in Supplier vetting process and maintaining Approved Supplier List.
• Provide support to Product Development and Operations on design transfer and process validations.
• Participate in product risk assessment efforts, including failure mode effect analysis (FMEA’s).
• Monitor quality metrics and key process indicators to identify opportunities.
• Lead and/or participate in multi-departmental initiatives to implement quality improvements.
• Drive compliance to the QMS and provide QMS training to appropriate team members.
• Author changes to existing procedures, work instructions, and forms as necessary.
• Comply with U.S. FDA and ISO requirements, other regulatory requirements, Company policies, operating procedures and processes.
• Perform other QA and quality control functions as necessary, with appropriate training.
• Assist in the review of Technical Files.

Requirements

• Minimum of 3-years quality assurance experience in medical device industry. Manufacturing or supplier quality engineering experiences a plus.
• Working knowledge of CFR Part 820 and 13485 for medical device products.
• 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 and experience in a manufacturing environment a plus.
• Good verbal (including presentation) and written communication skills.

About Onkos Surgical

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.

• Find solutions to our patients’ unmet clinical needs and advocate for their cause.
• Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.
• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
• Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
• Deliver value to our customers and shareholders.