Quality Engineer II — Medical Device Quality & Process

Bioventus; Memphis (TN); On-site; USD 70,000 - 100,000; Full time

Job summary

Bioventus is seeking a Quality Engineer II to support Manufacturing, Engineering, and QA in delivering high-quality medical devices. The role focuses on design controls, process validation, and statistical analysis to improve product quality and compliance.

You will work with cross-functional teams to ensure regulatory alignment and drive sustainable quality improvements across development, transfer, and production stages.

Qualifications

• Bachelor’s degree in an Engineering discipline with emphasis in quality engineering preferred.
• 2+ years’ experience in medical device quality engineering with understanding of regulations including ISO 13485 and 21 CFR 820.
• Experience interpreting regulations for supplier quality and development of electro-medical equipment/software including IEC 60601-1 family, ISO 62304, 62133, 14971 and EMC requirements.
• Data analysis and critical thinking; proficient in statistical methods, DOE, gauge R&R, SPC.
• Familiar with quality tools and process development/validation (IQ/OQ/PQ).
• Interaction with suppliers, manufacturing, and support organizations.

Responsibilities

• Supports regulatory requirements (design control) and process/product goals.
• Manages multiple schedules and competing priorities.
• Helps create specifications and transfer activities (gage design, inspection, GRR, capability studies).
• Facilitates design reviews ensuring quality considerations throughout product development.
• Guides on significant process/product problems and discusses customer issues with Marketing/Sales as needed.
• Analyzes KPI data (line yields, final release, supplier performance, customer experience) for improvements.
• Utilizes SAP for failure analysis and supports quality systems (audits, CAPA, investigations).
• Adheres to Bioventus Code of Compliance and internal controls.

Skills

Quality engineering

Regulatory knowledge

Data analysis

DOE

Gage R&R

Team work

Communication

Education

Bachelor's degree in Engineering

Tools

SAP

Job description

Bioventus is seeking a Quality Engineer II to support Manufacturing, Engineering, and QA in delivering high-quality medical devices. The role focuses on design controls, process validation, and statistical analysis to improve product quality and compliance.

You will work with cross-functional teams to ensure regulatory alignment and drive sustainable quality improvements across development, transfer, and production stages.