The Sr Quality Engineer provides quality engineering expertise to manufacturing, engineering, quality control/assurance and process/product development teams to ensure our products are designed and manufactured to a high level of quality, and compliant with medical device regulations.
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.
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