Supplier Quality Engineer

• 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.

• Defining and approving PPAP requirements for new and revised purchased parts, ensuring their on-time completion.

• 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).

• Partnering with departments like Post Market Surveillance, Quality Engineering, Manufacturing Engineering, and R&D to address supplier-related complaints and challenges.

• Maintaining complete and accurate supplier quality records, ensuring compliance with regulatory standards.
• Supporting audits as a subject matter expert, with occasional travel required.

• Continuously training on applicable procedures to stay up-to-date with regulations and quality standards.

• Going to the “Gemba” (where the action is) to understand the root cause of problems and implement practical solutions.

• 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.

• 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

Hologic