Quality Engineer II - Device Complaints

Quality Engineer II - Device Complaints

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Quality Engineer II – Device Complaints role is responsible for managing and executing complaint investigations for medical devices, identifying root causes, implementing corrective and preventive actions (CAPAs), and ensuring timely and compliant closure of complaint records. It serves as a technical and quality liaison between Manufacturing, R&D, Regulatory Affairs, and other cross‑functional partners to ensure customer feedback drives continuous product and process improvement.

In addition, this position may provide day‑to‑day guidance and oversight to Quality Technicians supporting complaint investigations, incoming inspection, and related quality operations activities.

• Lead and document complaint investigations in compliance with FDA 21 CFR Part 820, ISO 13485, and internal Quality System procedures.
• Evaluate incoming complaints for reportability and product impact.
• Coordinate and perform root cause analyses, including detailed failure investigations and risk assessments.
• Collaborate with Engineering, Manufacturing, and Supplier Quality to drive corrective and preventive actions (CAPAs).
• Identify complaint trends through data analysis and support ongoing product risk evaluations.
• Author and revise quality system documents (procedures, work instructions, forms) related to complaint handling and post‑market surveillance.
• Support internal and external audits by providing documentation and investigation summaries.
• Provide day‑to‑day guidance and oversight to Quality Technicians supporting complaint documentation, inspection activities, and related QA processes.
• Participate in cross‑functional teams to support nonconformance investigations and field corrective actions as needed.
• Partner with the Post‑Market Surveillance team to ensure complaint data is accurately captured and analyzed for trend reporting.
• Maintain compliance with company training requirements and participate in continuous improvement initiatives.
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Other duties as assigned

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field (required).
• Minimum 2 years of experience in Quality Assurance or Quality Engineering within a medical device, pharmaceutical, or regulated manufacturing environment.
• Demonstrated experience with device complaint handling, failure analysis, and root cause investigation (required).
• Knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485, ISO 14971, and MDR/Vigilance reporting requirements.
• Proficient in CAPA processes, risk management, and statistical data analysis.
• Strong technical writing and analytical skills; able to summarize complex information clearly.
• Excellent communication and collaboration skills across cross‑functional teams.
• Proficiency in Microsoft Office and quality management systems (Track Wise, EtQ, or equivalent preferred).
• CQE (Certified Quality Engineer) or related ASQ certification (preferred).

Reports to:

Manager, Quality Assurance

Direct Reports:
Quality Techs

Apply now! Hit the “Apply” button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.

All individuals, regardless of personal characteristics, are encouraged to apply.