Job Description


Quality Manufacturing Engineer

View: 2637

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


Job Title

Quality Manufacturing Engineer

Job Description

Effective January 4th, 2021, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips.  Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation. 

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 make life better 

As a Process Quality Engineer, you will have the ability to oversee the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality systems.

 

You are responsible for  

 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.

The Process Quality Engineer (QE) Oversees the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality systems.

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 for this role include:

  • Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
  • Performs independent technical assessment on product quality performance and post-market product quality analysis
  • Can Lead quality related problem solving and root cause analysis during design and manufacturing
  • Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
  • Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
  • Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Work 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.

 

You are part of 

Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.

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. 

To succeed in this role, you’ll need a customer-first attitude and the following 

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:

  • A Bachelor’s degree in engineering or science or equivalent experience in the medical device industry
  • 5+ years of related experience.
  • Working knowledge of appropriate global regulations, requirements, and standards.
  • ASQ certified Quality Engineer desired
  • Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
  • Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
  • Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
  • Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
  • Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems.

In return, we offer you 

We welcome you to a challenging, innovative environment with great opportunities for you to explore.

 

 

 





More Info / Apply

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