Process Quality Engineer
Job TitleProcess Quality Engineer
Process Quality Engineer – Highland Hts, OH (Philips HealthTech)
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.
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:
Responsible for (but not limited to) the following (as assigned)
- QA review/leadership for process validation protocols and reports
- QA review/leadership for process pFMEAs
- QA review/leadership for product nonconformance investigation activities
- QA review/leadership for equipment controls (Calibration and Preventative Maintenance)
- QA review/leadership for equipment specification and qualification
- QA review/leadership for CAPA investigation activities
- QA review/leadership for design/process changes (ECO/CRB)
- Support of Regulatory agency audits and inspections in areas of responsibility
- Interface with cross-functional teams to ensure compliance and timely product releases
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: Highland Hts, OH
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:
- Bachelors degree in QA, Engineering or related field OR equivalent (i.e. high school diploma/GED plus 4 years working experience within QA engineerin gin the medical device industry)
- 3-5 years of relevant experience in the following:
- Experience with CAPA processes including investigational techniques
- Experience with Control of Nonconforming product and risk assessments
- Experience with equipment controls (CAL/PM, equipment specifications)
- Experience with Risk Assessment (e.g. pFMEAs)
- Working knowledge of medical device regulations (including FDA QSRs, ISO13485)
- Working knowledge of production and process controls, including process validation
- Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability o comprehend and execute procedures, demonstrated understanding of system documentation)
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.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips’ dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
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.
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.
Mike Diamond – [email protected]
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