Job Description

Quality Manufacturing Engineer

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Company: Philips
Contract: PERM
Location: Murrysville, Pennsylvania, United States

Job Title

Quality Manufacturing 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 to

Develop, establish, and maintain quality systems and practices which meet the requirements established by Philips, customers, and regulatory agencies. You’ll serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives. Leads efforts in the identification of processes related to the manufacturing of components, sub-assemblies, and completed products. Support the realization and delivery of various products, key business improvement programs, and work with cross-functional teams from various geographical sites. The key challenge is to contribute to the success of Philips by managing Q&R challenges on both process and product level.

You are responsible for

  • Accountable for performing timely quality engineering and quality assurance tasks
  • Ensures Manufacturing quality systems are maintained and Documented.
  • Participates and supports the completion of New Product Introduction and Product transfers in the factory.
  • Reports on project timelines and tracking of product transfers.
  • Performs reviews of validation protocols and coordination of production builds to support validation activities.
  • Analyzes data for reports and validation activities as well as process improvement initiatives.
  • Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
  • Responsible with Change Management to manufacturing process or controls and NC/QN Management Process.
  • Analysis of defect for determining disposition of non-conformances.
  • Contribute to Operations performance monitoring, reporting, improvement, and development.
  • Assists Supplier Quality with investigations and may assist with Supplier Communications, as required.
  • Oversees Material Review board activities for non-conformance disposition management

You are a part of

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious, and agile within a fast-changing industry.

Our vision is to work together with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.

To succeed in this role, you should have the following skills and experience

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
  • Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science, electronics, Engineering or information technology.
  • Minimum of 5+ years’ experience in Quality Engineering in an FDA regulated, ISO 13485 QMS, Medical software or systems, product environment preferred
  • Experience managing and delivering CAPA’s, FMEA, Risk Management, Root Cause Analysis, Troubleshooting
  • Competency working with requirements of FDA 21 CFR Part 820, ISO 13485, ISO 62304, ISO 14971, MDD, MDR and ISO 9001
  • Managing FDA Inspections and providing Internal and External Audit Support
  • Overseeing / Approving Design Verification/Validation plans, protocols, and reports
  • Working knowledge of appropriate global regulations, requirements, and standards
  • Good skills in reporting, both in writing and oral
  • Project management knowledge and skills.
  • Experience in using problem solving tools

In return, we offer you

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.





More Info / Apply

(external link to recruiter web page)

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Last update 10 Sep 2021
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