Quality Engineer/Supplier Management

Work Your Magic with us

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.

Your role

Supplier Quality Engineer supporting LS Supplier Quality for our APAC manufacturing sites as well as supporting External Manufacturing (EM) of Life Science you are responsible for ensuring that products manufactured by external suppliers in China in your area of responsibility meet quality standards, customer and regulatory requirements. You act as the quality leader to represent Quality & Manufacturing on cross-functional teams internally and externally to support business needs. You will also work with our APAC manufacturing sites to ensure compliance to the LS Supplier Quality Policies.

Who you are

Minimum Requirements

• Bachelor's degree in chemical, biological engineering and minimum of five (5) years of progressively more responsible experience in Quality Assurance or Quality Engineering and supplier management in biotechnology industry.
• Alternatively, master's degree in chemical, biological engineering and minimum of three (3) years of progressively more responsible experience in process/quality engineering and supplier management in biotechnology industry.

Preferred Requirements

• Candidate must have at least three (3) years of work experience in Supplier Quality Management.
• ethical and practical knowledge of Chemicals, media/filters, o-rings/gaskets, and injected molded components gained through at least three (3) years of work experience.
• Experience with New Product Introduction a plus
• Must have demonstrated ability to perform failure analysis of customer complaints gained through at least three (3) years of work experience.
• Must have demonstrated ability to 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 three (3) years of work experience.
• Must have demonstrated knowledge of current ISO and cGMP standards and lead audit experience for supplier and internal audit gained through at least three (3) years of work experience.
• Excellent oral and written communication skills
• Excellent analytical, problem-solving and decision-making skills
• Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks with varying requirements and deadlines
• Fluent in English
• Trackwise, SAP, ManGo, Veeva, Oracle

(All years of experience may be gained concurrently.)

• Supplier quality management

• Independently manage and engage in day-to-day interaction with suppliers to ensure on-time-delivery of goods and solving quality/production related issues.

• Evaluation, monitoring, and quality improvement of external suppliers.
• Responsible for developing robust supplier relationships with your internal partners utilizing company's values.
• Work closely with cross functional teams incl. Supply Chain, R&D, Procurement, and Trade Compliance to ensure product delivery and quality meets quality standards, customer and regulatory requirements.
• Lead supplier assessments and conduct trend analysis to ensure robust process/product quality.
• Resolve design, workmanship, material, and process issues affecting product quality.
• Lead supplier quality improvement teams, manage supplier yield/data reporting, and ensure continuous improvement of quality and efficiency of external manufacturing operations.
• Facilitate quality review meetings to ensure follow-up of issues and implementation of Corrective and Preventative actions.
• Actively support the delivery of key site metrics (e.g. Complaint reduction)
• Lead Engineering Change Requests for evaluation of changes to manufacturing specifications/drawing/procedures.
• Provide technical assistance to address customer complaints and chronic supplier issues.
• Perform supplier audits for ISO 13485 and ISO 9001 and develop corresponding audit reports.
• 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

• Responsible for working with all LS APAC sites to drive and implement Supplier Quality Management Policies

• Provide training and guidance

• Drive completion of site level project plans to support initiative deliverables
• Assess site supplier quality engineer skills and competencies and provide or facilitate required training and mentoring as gaps are identified
• Lead and or participate in site team meetings.
• Drive the implementation of supplier quality agreements
• Assist and participate on integration teams as needed
• Define, train, and implement Supplier Quality Management program at recently acquired sites as required.
• Schedule and lead Supplier Quality site audits to ensure compliance to LS global management procedure.
• Develop and or change relevant site and or LS procedures as needed.
• Schedule and perform supplier audits for other Millipore Sigma sites as needed.
• Provide Technical assistance as needed, to address customer complaints, chronic supplier issues, etc. to prevent recurrence.
• Active team member on related supply chain teams.
• Ensures Millipore Sigma's Purpose, Vision, and Values are practiced in the performance of the position responsibilities to meet or exceed our Customers' expectations.

Position may also require 20% travel

What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity