Senior Quality Engineer – Medical Devices & Compliance

Bioventus LLC; Memphis (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

Bioventus LLC is seeking a Quality Engineer to ensure design control and regulatory compliance (21 CFR 820, ISO 13485) across product development and processes.

You will lead GR&R, CAPA investigations, process validation (IQ/OQ/PQ) and work with design teams to meet quality goals, with strong emphasis on risk management and DFMEA/PFMEA.

Join a diverse team dedicated to improving medical devices and patient outcomes, with opportunities to influence quality systems and supplier performance.

Qualifications

• Bachelor’s degree in an Engineering discipline; Masters preferred.
• 5 years (BS) or 4 years (MS) in medical device industry with ISO 13485 and 21 CFR 820 knowledge.
• Strong experience with process and product development, validation (IQ,OQ,PQ) and GD&T.

Responsibilities

• Ensure regulatory requirements (21 CFR 820, EU MDR, ISO 13485:2016) are met using project planning and execution.
• Lead design transfer activities including gage design, inspection processes, GR&R, capability studies and process validation.
• Participate in Design Review activities and guide quality considerations during PLM stages of development.
• Provide guidance to solve significant process or product problems and discuss customer concerns with Marketing and Sales as needed.
• Generate and present KPI reports on quality metrics to internal teams.
• Support Quality Systems such as CAPA, audits, and investigations; update procedures to meet regulatory requirements.

Skills

Regulatory knowledge

Quality engineering concepts

GD&T

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Job description

Bioventus LLC is seeking a Quality Engineer to ensure design control and regulatory compliance (21 CFR 820, ISO 13485) across product development and processes.

You will lead GR&R, CAPA investigations, process validation (IQ/OQ/PQ) and work with design teams to meet quality goals, with strong emphasis on risk management and DFMEA/PFMEA.

Join a diverse team dedicated to improving medical devices and patient outcomes, with opportunities to influence quality systems and supplier performance.