Supplier Quality Engineer

Merck KGaA Darmstadt Germany • Burlington, MA

96d • $87,000 - $130,400

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Requirements

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, or other Engineering discipline.
• 3+ years of work experience in quality assurance or quality engineering role within supplier management in the biotechnology industry.
• OR Master's degree in Chemical Engineering, Biomedical Engineering, Electrical Engineering, or other Engineering discipline and 1+ years of experience in process/quality engineering and supplier management in biotechnology industry.
• 1+ years of work experience in Supplier Quality Management.

Nice To Haves

• Excellent oral and written communication skills.
• Practical knowledge of media/filters, chemicals, O-rings/gaskets, and injected molded components gained through 1+ years of work experience.
• Demonstrated ability to perform failure analysis of customer complaints gained through 1+ years of work experience.
• Excellent analytical, problem-solving and decision-making skills; self-directed and self-motivated with excellent organizational skills.
• Ability to prioritize and work effectively on multiple tasks with varying requirements and deadlines.
• Create, review, and approve Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Master Validation Plans (MVP), and Product Validations (PV) gained through at least 1+ years of work experience.
• TrackWise, SAP, Oracle, ManGo, Veeva experience is a plus.
• Knowledge of current ISO and cGMP standards and lead audit experience for supplier and internal audit gained through 1+ years of work experience is a plus.
• Experience with new product introduction and buy/resell processes is a plus.
• Experience managing chemical suppliers is a plus.

Responsibilities

• Independently manage and collaborate with suppliers to ensure on-time delivery, resolve quality and production issues, drive continuous improvement, and act as the primary liaison between suppliers and internal cross-functional teams.
• Conduct audits, monitor performance, and foster strong, trust-based partnerships to ensure compliance with quality, customer, and regulatory standards.
• Lead and facilitate problem-solving activities with suppliers using methodologies like 8D, 5Why, and Ishikawa diagrams to implement effective corrective and preventive actions (CAPA).
• Lead supplier quality improvement teams, manage supplier yield/data reporting, and ensure continuous improvement of quality and efficiency of external manufacturing operations.
• Lead supplier quality review meetings to ensure follow-up of issues and implementation of Corrective and Preventative actions.
• Perform supplier and internal audits for ISO 13485 and ISO 9001 and develop corresponding audit reports.
• Support the achievement of key site metrics, such as complaint reduction, by leading Engineering Change Requests related to manufacturing specifications, drawings, and procedures.
• Provide technical assistance to resolve customer complaints and chronic supplier issues.
• Develop qualification and validation documentation to support changes to existing products and/or processes.
• Collaboration and development of Incoming Quality requirements and Statistical analysis of incoming and Supplier process data.
• Drive continuous improvement initiatives to enhance performance, quality and efficiency of external suppliers.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree