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Supplier quality engineer

Gand
Hologic Europe
Publiée le Publiée il y a 2 h
Description de l'offre

PAre you passionate about ensuring the highest standards of quality and regulatory compliance in a dynamic environment? Do you excel at building strong supplier relationships and driving continuous improvement? If so, we have an exciting opportunity for you to join our team as a strongSupplier Quality Engineer /strong in Brussels, Belgium. /ppThis is your chance to contribute to impactful work in the medical device industry, where your expertise will directly support our mission of improving lives through innovation and quality. /ppstrongWhat to Expect: /strong /ppstrongSupplier Quality Oversight /strong /pul liExecuting activities to ensure compliance with regulatory standards and the Quality Management System. /li liConducting technical reviews of suppliers to assess their capability to manufacture materials and meet required standards. /li liOverseeing, assessing, and monitoring supplier performance in areas like manufacturing, process control, quality control practices, corrective actions, and continuous improvement. /li /ulpstrongProduction Part Approval Process (PPAP) /strong /pul liDefining and approving PPAP requirements for new and revised purchased parts, ensuring their on-time completion. /li /ulpstrongSupplier Issue Management /strong /pul liIssuing and following up on Agile Quality figures like SCARs, SACAs, and NCEs related to suppliers, ensuring workflows comply with established KPIs. /li liCollaborating with suppliers on problem-solving, root cause analysis, and implementing corrective actions to avoid repeat issues. /li liResolving day-to-day quality issues with suppliers by addressing non-conformities and coordinating material disposition (e.G., returns, rework, sorting). /li /ulpstrongCross-Functional Collaboration /strong /pul liPartnering with departments like Post Market Surveillance, Quality Engineering, Manufacturing Engineering, and RD to address supplier-related complaints and challenges. /li /ulpstrongAudits and Documentation /strong /pul liMaintaining complete and accurate supplier quality records, ensuring compliance with regulatory standards. /li liSupporting audits as a subject matter expert, with occasional travel required. /li /ulpstrongTraining and Development /strong /pul liContinuously training on applicable procedures to stay up-to-date with regulations and quality standards. /li /ulpstrongGemba Mindset /strong /pul liGoing to the “Gemba” (where the action is) to understand the root cause of problems and implement practical solutions. /li /ulpstrongWhat We Expect: /strong /ppstrongQualifications Knowledge: /strong /pul listrongEducation: /strong Bachelor’s degree in Engineering (Biochemical, Chemical, or related field). An ASQ Supplier Quality Engineer Certificate is a plus. /li listrongRegulatory Expertise: /strong Knowledge of EU MDR/IVDR, CFR820, ISO 13485, Medical Device Single Audit Program, and other international regulations. Experience with automotive PPAP is a plus. /li listrongIndustry Experience: /strong 5+ years’ experience in medical device manufacturing or a related industry, with 3+ years in a Quality function preferred. /li listrongProblem Solving: /strongProficiency with problem-solving tools such as SPC, Total Quality Management, and root cause analysis. /li listrongStrong Communicator: /strong Ability to effectively communicate at all levels of the organisation, both written and verbal. /li listrongAnalytical Mindset: /strong Skilled at analyzing data, evaluating factors, and translating insights into actionable plans. /li listrongSelf-Motivated: /strong Able to work independently with minimal supervision, while managing multiple complex projects. /li /ulpstrongWhy Hologic? /strong /pul liWork on impactful projects that make a difference in the medical device industry. /li liBuild relationships with suppliers around the globe, develop your skills and grow your career in a supportive and collaborative environment. /li liCompetitive salary and benefits package, including health insurance /li /ulpbr /strongTravel Requirements: /strong 15-20%br /strongLanguage Requirements: /strong Proficient in English (written and oral). A second language is a plus. /pp#LI-HE1 /p

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