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MilliporeSigma

Supplier Quality Engineer

MilliporeSigma, Burlington, Massachusetts, us, 01805

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Work Your Magic with us! Start your next chapter and join MilliporeSigma. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Overview

As a Supplier Quality Engineer, you will 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. You will conduct audits, monitor performance, and foster strong, trust-based partnerships to ensure compliance with quality, customer, and regulatory standards. Responsibilities

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 preventive 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, and by providing technical assistance to resolve customer complaints and chronic supplier issues. Develop qualification and validation documentation to support changes to existing products and/or processes. Collaborate on 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. Who You Are

Minimum Qualifications

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

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 Excellent analytical, problem-solving and decision-making skills; self-directed and self-motivated with strong organizational skills Experience creating, reviewing, and approving Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Master Validation Plans (MVP), and Product Validations (PV) Experience with TrackWise, SAP, Oracle, ManGo, Veeva is a plus Knowledge of current ISO and cGMP standards and lead audit experience for supplier and internal audits is a plus Experience with new product introduction and buy/resell processes is a plus Experience managing chemical suppliers is a plus Pay Range and Benefits

Pay Range for this position: $87,000.00 - $130,400.00 annually. The offer range represents the anticipated low and high end of the base pay; actual compensation is determined by factors such as location, experience, education, and skills. Position may be eligible for sales or performance-based bonuses. Benefits include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information, click here. What we offer: We are curious minds from diverse backgrounds and experiences. We are committed to inclusion and belonging and to helping you develop and grow at your own pace. Join us in building a culture that empowers everyone to work their magic and champion human progress. Apply now and become part of a team dedicated to Sparking Discovery and Elevating Humanity! Note: This job posting may reflect current needs and could be subject to change.

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