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As a Senior Supplier Quality Engineer, you have a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. You will build a partnership culture with the supply chain with transparency, coaching, and adapting to our continuous improvement philosophy. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position. Job Description

As a Senior Supplier Quality Engineer, you have a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. You will build a partnership culture with the supply chain with transparency, coaching, and adapting to our continuous improvement philosophy. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.

Responsibilities

Conduct supplier assessments and audits to evaluate their capabilities, processes, and quality management systems to meet our regulatory requirements. Assist in the selection and qualification of new suppliers based on established procedures. Develop periodic reports on supplier performance (scorecards). Establish and maintain periodic reviews with suppliers on their performance, and improvement plan. Maintain detailed records of supplier audits, quality performance, and corrective action plans. Report on supplier quality performance during cross-functional meetings and provide recommendations for improvement. Create supplier quality reports, including analysis on defect trends, root causes, and long-term resolutions. Ensure effective implementation of corrective actions and track results to ensure continuous improvement. Lead resolution of supplier related non-conformances using problem solving tools (8D, Fishbone, 5 WHY's, etc.). In-depth understanding of manufacturing processes, including machining, fabrication, casting, injection moulding, and assembly processes. Ability to assess the quality impact of supplier manufacturing changes and deviations. Must have excellent problem-solving abilities using systemic, logical, and sequential approaches and provide technical oversight for issue/problem resolution activities. Comprehensive knowledge of TMV's, process and product validations (i.e., IQ, OQ, PQ). Ability to independently execute supplier process validation. Advanced knowledge of quality management tools, including, but not limited to (SPC, FMEA, MSA, DOE, and Quality Systems). Support continuous product and process improvement through detailed failure analysis for nonconformance's, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective, and remediation action plans, and for corrective and preventive actions.

Requirements:

Bachelor's degree preferably in an engineering or scientific discipline. 5+ years' experience working in manufacturing of finished medical device or related industry. Working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, and the EU Medical Device Directive. Lead auditor credentials for QSR, ISO, or MD SAP, and EU MDR are desired. (Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Knowledge of probability, statistical quality control and design of experiments, Minitab proficiency preferred. Knowledge of geometric design and tolerance (GD&T) and gage design tolerance preferred. Seniority level Seniority levelMid-Senior level Employment type Employment typeContract Job function Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Supplier Quality Engineer jobs in San Jose, CA . Menlo Park, CA $122,000.00-$169,000.00 2 weeks ago Newark, CA $98,700.00-$127,800.00 1 month ago San Jose, CA $90,000.00-$120,000.00 1 month ago Staff Supplier Quality Engineer - MechanicalSupplier Quality Engineer - Electromechanical (Hybrid Mechanical and Electrical)Staff Supplier Quality Engineer - Mechanical San Jose, CA $150,000.00-$250,000.00 3 months ago Quality Engineer - Technical Cleanliness - Battery Cell Manufacturing San Jose, CA $124,400.00-$175,000.00 1 week ago Supplier Industrialization & Quality Engineer - PCBA Sunnyvale, CA $140,000.00-$220,000.00 1 month ago Principal Supplier / Manufacturing Quality Engineer Redwood City, CA $112,700.00-$155,000.00 3 weeks ago Fremont, CA $145,000.00-$160,000.00 4 days ago Fremont, CA $145,000.00-$160,000.00 2 days ago Mountain View, CA $135,000.00-$216,000.00 1 week ago Manufacturing Engineer, Product Operations Sunnyvale, CA $138,000.00-$202,000.00 2 weeks ago Interconnect Industrialization and Supplier Quality Engineer We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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