Philips Quality Assurance Engineer in Highland Heights, Ohio
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.
Supports product development programs (new and sustaining). Leads proactive design assurance activities facilitating the development and release of high quality products. Ensures standard and process compliance. Provide guidance and support during investigation and resolution of product quality or compliance issues. Emphasis placed on knowledge of standards, regulations, investigative/root cause processes, and procedures supporting compliance to industry, PQMS, DI and CT/ AMI product quality standards and requirements. Provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners. Guiding, coaching and training respective to investigative methods, risk mitigation techniques, and general product safety.
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 quality of the design through compliance with design controls.
Provide guidance of Design Controls and the Product Realization Process (PRP) to the project teams.
Support the establishment and maintenance of design and development plans in support of quality and compliance for program and project assigned.
Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population.
In collaboration with product development, recommend/promote testing methodologies and approaches required to confirm that the design output meets the design input for program and projects assigned.
Participate in the review of clinical relevant test methods, design verification test plans and results, and validation test plans and results.
Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to ensure device master record is complete and provide guidance to design engineering, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation.
Works with Program Manager on Risk management activities including supporting risk management activities and essential requirements analysis.
Ensure completion of the functional actions items /tasks and submission of deliverables to the document control system and report on functional group progress to team (including escalation and program review).
Supports compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness.
Participates in the defects classification, defect risk analysis and investigations.
Participates in reviews related to design, validation, defect classification and documentation as required.
Responsible for ensuring defects, design changes and document changes are processed timely and compliantly as applicable.
Support Post Market Product Assurance, audit group, and other business partners in post-market activities.
Work with a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries.
Support program managers with identification and maintenance of program team interdependencies.
Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development.
Provide regular technical and administrative input to business partners.
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.
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.
Bachelor's degree in engineering/science discipline or technical certification in related field
3-5 years of relevant experience in product design and development or related work experience
Experience as a contributing member of a team to take design from concept into production
Experience with medical device regulations
Regulatory compliance awareness such as FDA design controls CFR 820, ISO 14971, ISO 13485, IEC60601, IEC62304 and similar
CRE / CQE Certification
Six Sigma / Design for Reliability / Design for Manufacturability experience
Working knowledge of FEA simulation tools and analysis
Regulatory compliance awareness including design controls and risk management in a regulated industry
Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
Ability to learn quickly and respond to changing priorities
Must have strong interpersonal communication skills as well as being a motivated team player
Ability to work with global QA, RA organization
Technical writing and presentation skills
Good verbal and written communication skills, good team skills including project management
Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)
Vocational English in writing
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.
Find out more info about Philips at 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.
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.