Sr. Quality Engineer AHT Advance Healing Therapies
Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT
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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. Who are Bioventus? We are the market leader in developing clinically proven and cost-effective orthobiologic solutions for surgical and non-surgical bone healing and osteoarthritis, with products recognized for their safety, innovation and effectiveness. $350+ million in annual revenue 700 employees worldwide Helping 440,000+ 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. Sr. Quality Engineer-AHT Advance Healing Therapies Full time, Office Based, Memphis TN The Senior Quality Engineer provides Quality Engineering expertise to Manufacturing, Engineering, Quality Control/Quality Assurance and Process/Product Development teams to ensure that our products are designed and manufactured to a high level of quality, while ensuring compliance with regulations governing medical devices. Ideal candidates have strong interpersonal skills and determination to provide the best possible experience to our customers and coworkers. They strive for excellent performance, driven by the willingness to both teach and learn. They are good team players, dynamic, optimistic, accurate, well-organized, and ambitious about developing as a professional. 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 specification needs/requirements and assist with the creation and/or modification of product and process specifications. Strong knowledge of medical device design and development processes. Support 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 ensure quality considerations during all 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 (KPI) 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. 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 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). 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 is required What you’ll receive The satisfaction of driving real change in the industry and people’s lives A diverse global community of people who are driven by a shared purpose to help patients A business that acts with integrity in all interactions with co-workers, leaders and customers We value others and build success by appreciating differences in thought, opinion, background, skills and perspectives An environment of continuous learning and development Flat organizational structures which elevate employees’ level of responsibility Meaningful opportunities for professional development and mentoring Competitive compensation package, including bonus Exciting benefits package, including three weeks’ vacation; medical, dental and vision benefits; life insurance; and a 401(k) plan Are you the top talent we are looking for? now! Hit the button to send us your resume and cover letter. We are an equal opportunity employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply.