Bioventus · 4 days ago
Quality Engineer II - Device Complaints
Memphis, TN
Full-time
Onsite
Entry, Mid Level
2+ years expBioventus is a company focused on developing people and fostering a diverse team to help patients lead active lives. The Quality Engineer II – Device Complaints role involves managing complaint investigations for medical devices, ensuring compliance with relevant regulations, and collaborating with various departments to drive product improvement and corrective actions.
Health CareHealth DiagnosticsMedical Device
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical field
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
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
Preferred
Proficiency in Microsoft Office and quality management systems (TrackWise, EtQ, or equivalent)
CQE (Certified Quality Engineer) or related ASQ certification
Company
Bioventus
Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely.
1001-5000 employees
H1B Sponsorship
Bioventus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (5)
2023 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$827MKey Investors
Wells Fargo
2025-07-31Post Ipo Debt· $400M
2022-04-26Post Ipo Debt· $415M
2021-02-10IPO
Leadership Team
Mark Singleton
Senior Vice President and Chief Financial Officer
M
Miguel O. Beltran-Delgado
Senior Vice President Operations
Recent News
2025-12-09
Company data provided by crunchbase