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.
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