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Job Title Supplier Quality Engineer
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.In this role, you have the opportunity toto be a member of the a global SQE Team of Healthcare Informatics to manage mainly Software and Service suppliers in terms of purchasing controls to ensure excellent product quality and compliance. You own the implementation of Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain of the assigned business categoriesYou are responsible for- You will partner with R&D, Privacy & Security, Operations and Procurement Engineering to actively engineer quality and ensure compliance for components, Software, finished products etc., from suppliers.
- Developing and supporting regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
- You will lead additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records.
- Ensuring raw materials/components/products at supplier(s) are released from supplier(s) to Philips according to the agreed requirements.
- You will drive quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements.
- Driving shared accountability across stake holders to design, manufacture and distribute products right the first time from our supplier base.
- You will drive product implementation/Changes/Transfers accordingly the Philips requirements (NPIs, PDLM, APQP)
- You will be responsible to managing SCARs, supplier QN's, unintended disruptions, and resolve supplier issues to business and regulatory compliance satisfaction.
- Performing of Supplier Audits and leading Supplier Quality Improvement programs.
- Leading the implementation of robust purchasing controls for the assigned business categories.
- Able to work in global cross functional Teams Project Management, especially to managing NPI projects (APQP) in particular for Software.
- Bachelor's degree in an engineering or science discipline, or equivalent experience.
- Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course.
- 6+ years of related experience in a medical device or regulated industry.
- 4+ years of Project management experience
- Working knowledge of appropriate global medical device regulations, requirements, and standards such as FDA 21 CFR Purchasing Controls 820, ISO13485, ISO14971, IEC 62304, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282) and ISO 9001.
- Expert level knowledge of methodologies, tools and techniques in Purchasing, Operations and SQE including due diligence processes.
- Experience in Software Development (IEC 82304) is a plus.
- Preferred to have broader experience including procurement, manufacturing engineering and project engineering.
- Excellent commination skills and experience in performing of Supplier Audits.
- ID: #21628650
- State: Massachusetts Cambridge 02140 Cambridge USA
- City: Cambridge
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-24
- Deadline: 2021-12-20
- Category: Architect/engineer/CAD