Sr Quality Engineer

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

Are you ready to work for a more active world? 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.

What you'll be doing

Ensure medical device regulatory requirements (21 CFR 820, EU MDD/MDR, ISO 13485:2016 and IEC 60601 series) related to design control and process/product goals (e.g., process capability, yield, reliability) are met utilizing project planning and execution skills. Identify and manage needs/requirements and assist with the creation and/or modification of product and process specifications Lead design transfer activities focused in development of gage design, inspection processes, GR&R, capability studies and process validation Actively participate in Design Review activities of new products and work closely with product design teams to manage quality considerations during all PLM stages of product development Provide guidance and work to solve significant or chronic process or product problems. Discuss customer concerns or complaints with Marketing and Sales as needed Generate, analyze, and present reports on quality related Key Performance Indicators (KPIs) such as line yields, final release, supplier performance and customer experiences to internal product improvement teams Support Quality Systems such as delivery holds, internal and external audits, CAPA and investigations Update and revise procedures to consistently meet regulatory requirements such as EU MDR, IEC 60601 series, ISO 13485:2016, 21 CFR 820, etc. Analyze and act on process trend data including leading investigations, root cause analysis and assist with corrective actions. Hold 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

What you'll bring to the table

• Bachelor’s degree (Masters preferred), in an Engineering discipline or equivalent technical background, with emphasis or experience in electronics, circuits and/or software.
• Electrical Engineering or related fields preferred.
• Minimum 5 years (with Bachelor’s) or 4 years (with Master’s) of experience within the medical device industry with a comprehensive understanding of, and ability to interpret regulations and guidelines governing medical devices including ISO 13485 and 21 CFR 820 and EU MDD/MDR.
• Strong working knowledge of process and product development and validation methodologies (IQ,OQ,PQ).
• Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations.
• Understanding and experience in applying quality engineering concepts such as process capability analysis, risk management, PFMEA and DFMEA.
• Previous Quality Engineering or Product Development experience and GD&T and electronics knowledge/experience is required.

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.

$500+ million in annual revenue

1100+ employees worldwide

Helping 700,000+ people every year

The Bioventus team always puts patients at the forefront, and their needs are the priority in the choices we make and actions we take.