Shanghai, CHN
12 days ago
Staff Quality Engineer - Supplier Management
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and X (http://twitter.com/embecta) .  **Why join us?** A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. + Serve as a partner with Research and Development (R&D) and 3rd Party Manufacturing in the development of new products and processes through active design review, vendor sourcing and qualification, direct reliability testing and perform post-market surveillance. + Support contracted manufacturer to formalize pre-production quality assurance, perform process validations and reliability testing; ensure conformance to product standards. + Ensure all manufacturing operations at contracted manufacturers associated with the development, manufacture, procurement, and release of products are performed in compliance with embecta requirements and appropriate regulations (federal and international). + Manage and perform initial evaluations of new suppliers, and re-evaluation of existing suppliers, leading audits of proposed new and existing suppliers, performing risk assessment and evaluation of suppliers. + Establish and finalize quality agreement based on the project needs with contracted manufacturers + Report risks and suspected/known issues from the contracted manufacturer and suppliers, which may jeopardize patient safety or compliance with regulatory standards. + Monitor contracted manufacturer/suppliers’ quality assurance level and liaise with corporate supplier quality on projects as required. + Prepare and maintain supplier related documentation in compliance with the appropriate regulatory requirements. + Support/Guide contracted manufacturer in continuous improvement activities (Six Sigma etc.). + Support/Guide contracted manufacturers/suppliers to investigate customer complaints when applicable. + Review quality data prepared by contracted manufacturers and report out to management team. + Become an active member of the site internal audit team. embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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