BEL
47 days ago
Supplier Quality Engineer
Supplier Quality Engineer Belgium Liege, Belgium Are 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 **Supplier Quality Engineer** in Brussels, Belgium. This 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. **What to Expect:** **Supplier Quality Oversight** + Executing activities to ensure compliance with regulatory standards and the Quality Management System. + Conducting technical reviews of suppliers to assess their capability to manufacture materials and meet required standards. + Overseeing, assessing, and monitoring supplier performance in areas like manufacturing, process control, quality control practices, corrective actions, and continuous improvement. **Production Part Approval Process (PPAP)** + Defining and approving PPAP requirements for new and revised purchased parts, ensuring their on-time completion. **Supplier Issue Management** + Issuing and following up on Agile Quality figures like SCARs, SACAs, and NCEs related to suppliers, ensuring workflows comply with established KPIs. + Collaborating with suppliers on problem-solving, root cause analysis, and implementing corrective actions to avoid repeat issues. + Resolving day-to-day quality issues with suppliers by addressing non-conformities and coordinating material disposition (e.g., returns, rework, sorting). **Cross-Functional Collaboration** + Partnering with departments like Post Market Surveillance, Quality Engineering, Manufacturing Engineering, and R&D to address supplier-related complaints and challenges. **Audits and Documentation** + Maintaining complete and accurate supplier quality records, ensuring compliance with regulatory standards. + Supporting audits as a subject matter expert, with occasional travel required. **Training and Development** + Continuously training on applicable procedures to stay up-to-date with regulations and quality standards. **Gemba Mindset** + Going to the “Gemba” (where the action is) to understand the root cause of problems and implement practical solutions. **What We Expect:** **Qualifications & Knowledge:** + **Education:** Bachelor’s degree in Engineering (Biochemical, Chemical, or related field). An ASQ Supplier Quality Engineer Certificate is a plus. + **Regulatory Expertise:** Knowledge of EU MDR/IVDR, CFR820, ISO 13485, Medical Device Single Audit Program, and other international regulations. Experience with automotive PPAP is a plus. + **Industry Experience:** 5+ years’ experience in medical device manufacturing or a related industry, with 3+ years in a Quality function preferred. + **Problem Solving:** Proficiency with problem-solving tools such as SPC, Total Quality Management, and root cause analysis. + **Strong Communicator:** Ability to effectively communicate at all levels of the organisation, both written and verbal. + **Analytical Mindset:** Skilled at analyzing data, evaluating factors, and translating insights into actionable plans. + **Self-Motivated:** Able to work independently with minimal supervision, while managing multiple complex projects. **Why Hologic?** + Work on impactful projects that make a difference in the medical device industry. + Build relationships with suppliers around the globe, develop your skills and grow your career in a supportive and collaborative environment. + Competitive salary and benefits package, including health insurance **Travel Requirements:** 15-20% **Language Requirements:** Proficient in English (written and oral). A second language is a plus. \#LI-HE1
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