Design Control Quality Engineer - Field Action Sustaining Team - Philips (Cleveland, Ohio)
Posted: Saturday, February 10, 2018 2:10 PM
DESIGN QUALITY ENGINEER Your Challenge: As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve. You will lead proactive design assurance activities facilitating the development and release of high quality products, ensure standard and process compliance, provide investigative support/leadership when significant product quality issues arise. -Provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service and Field Service personnel, which may include coaching and training respective to investigative methods, risk mitigation techniques, and general product safety (inc. Six Sigma, FTA, FMEA, HALT, etc.). Responsibilities: Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). Key areas of responsibilities (KARS) for this role include: Integral member of product development team responsible for supporting activities required to ensure reliability of the design through compliance with design controls Provide guidance of Design Controls and the PRP process to the engineering core teams Key deliverable is to support and/or develop the Quality Plan or Quality Planning documentation for each program and project assigned Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target patient population In collaboration with product development, recommend/promote new testing methodologies and approaches required to complete reliability analysis of device designs Participate in the review of clinical relevant test methods and Design Verification test plans, execution and reports as required Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability and reliability. Provide guidance for development of manufacturing test/evaluation methods and process validation. Works with Program Manager on Risk management activities including supporting and leading FMEA/Risk Management activities and essential requirements analysis including standards review and evidence of conformity. Ensure completion of the functional actions items /tasks and submission of deliverables to the document control system. Report on functional group progress and issues to team (including escalation and program review) Supports audits and compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are met and audit findings appropriately addressed Ensuring DHF completeness as appropriate or required Participates in the Defects Classification, Defect-Risk Analysis forum and IR investigations Participates in all design, validation, defect classification and documentation reviews as required Responsible for ensuring their functional ECOs and DCOs are released Support Post Market Product Assurance and audit groups in post-market activities Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development. Your team As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world. Location: Cleveland, Ohio We are looking for: A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year. Specific skill requirements for this role include: Bachelor’s degree in engineering or science discipline 4-7 years related work experience in Design Quality Engineering with exposure to medical product or regulated process mature environment (FDA, CMMI, FAA, DoD) Mastered regulatory compliance awareness, including at a minimum FDA design controls CFR 820, ISO 14971, ISO 13485, IEC62304 Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity Experience in reliability characterization and demonstration test methods, including establishing relevant test parameters and test sample sizes Demonstrated experience and understanding in use of statistical tools Proven experience as a contributing member of a team to take design from concept into production Good verbal and written communication skills, good team skills including project management Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project) Desired/Preferred Qualifications CRE / CQE Certification Design for Lean Sigma (DFLS) / Six Sigma / Design for Reliability and Manufacturing (DRM) experience Working knowledge of FEA simulation tools and analysis Minitab experience Strong statistics background Experience with medical device regulations Our Offer: This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by. Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy. Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day. Contact: Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first. Apply today! @ www.philips.com/na/careers 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.
Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=143016&lang=en
• Location: Cleveland
• Post ID: 34698712 cleveland