Supplier Quality Engineer
Job TitleSupplier Quality Engineer
Supplier Quality Engineer (SQE) will manage all elements of supplier quality by identifying and driving improvement opportunities within the supply-chain. Support purchasing, manufacturing, operations and engineering functions as they related to supplier quality.
SQE will also interface with suppliers within the development and management of continuous product and process improvement activities. Daily interactions to develop receiving inspection plans, corrective action plan, oversee supplier nonconformance, conducting supplier assessments (audits), approve supplier product/process validations and ensure all Q&R requirements are met within a medical device manufacturing facility.
- Interface with ASL suppliers, engineering, operations, manufacturing, service/repair to implement effective supplier quality corrective actions (SCAR’s) and quality improvements minimizing cost of quality events.
- Monitor, analyze and report monthly supplier quality performance (DPPM, FFOR, Consumption, and Yield). Collect and maintain supplier quality performance metrics.
- Design and develop receiving inspection plans to ensure plans to ensure verification of purchased product is compliant to required material specifications.
- Management of PPAP (Purchased Parts Approval Process) to ensure product/process V&V activities, first article inspection of components, parts or high-level assemblies meet requirements as defined by Invivo-PH.
- Ensure supplier early involvement/input into product requirements and design specification and supplier participation in design reviews.
- Plan, schedule and conduct supplier on-site audits (QMS, product, process, for-cause) to ensure defined audit scope and Q&R requirements are met.
- Participate in the different nonconformance product reviews (MRB meetings) for disposition, defect documentation and RTV/RMA processing.
- Drive structural quality and process improvements such as quality agreements, risk assessments, supplier classifications, sustainability agreements, and quality specifications in collaboration with commodity managers, Q&R and engineering.
- Participate and support QMS management reviews for supplier quality key metrics.
- Support all quality and applicable regulatory functions (ISO13485, FDA 21 CFR 820) to resolve supplier related complaints, recalls, DFOA’s, CAPA’s, and SCAR’s.
- Ensure audit readiness for internal/external audits of purchasing and supplier quality controls.
- Develop positive relationships with supplier account managers (SAM’s) and Commodity Manger in the process of supplier change assessments (SCA’s), new product introductions (NPI’s) and supplier transfers.
We have a dynamic and rewarding career opportunity for Supplier Quality Engineer in Gainesville, Florida.
Invivo Corporation, a subsidiary of Philips Healthcare and world leader in MRI coils and related accessories, is looking to expand its Gainesville, FL team. Our vision is to deliver clinical solutions to our customers, whether indirectly through Original Equipment Manufacturers of MRI scanners, or directly to clinical MRI users. Our history is grounded in the expert development of MRI coils and more recently in the development of integrated clinical solutions like Functional MRI and the DynaCAD breast imaging system. Research and advanced development are at the core of the future of the MRI field and are a key part of Invivo’s strategy for growth.
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care.
Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
- Knowledge of RF Coil system designs, specification and analysis.
- Extensive knowledge of engineering and design principles related to Invivo coils products.
- Knowledge of IPC manufacturing standards.
- Ability to effectively utilize company provided software for engineering design, complaint tracking and document change management.
- Electronic manufacturing background, preferably in a Medical Device Manufacturing environment.
- The ability to provide timely and accurate reports of customer complaints and reported defects.
- Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
- Bachelor’s degree in an engineering discipline and 3+ years of medical device experience or equivalent combination of education and experience.
- ASQ – CQE, CQA, CSSBB or CSSGB preferred.
- Lean – Six Sigma experience preferred.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
In case of difficulties with your job application please send an email to [email protected]
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