Quality Engineer

at Philips
Location Latham, New York
Date Posted July 31, 2022
Category Engineering
Job Type Not Specified

Description

So whatever your role, if you share our passion for helping others, you ll be working towards creating a better and fairer future for all.

You are responsible for

As a member of the Plant Quality Operations team, your challenge will be to guide and support Plant Leadership and stakeholders 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.

Key areas of responsibilities for this role include:

  • Ensures that appropriate quality plans are made and a suitable quality system is in place that includes all stages of the manufacture of the product/system and supports Quality System design
  • Can Lead quality related problem solving and root cause analysis during design and manufacturing
  • 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.
  • Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems
  • Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.)
  • Review Quality records and process documents, pertaining to calibration, validation, environmental controls, training and work instructions.
  • Support external and regulatory audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls.
  • Execute CAPA for manufacturing related issues
  • You are a part of
    A team supporting manufacturing in Quality capacity in areas of CAPA, NC, Process quality inspection planning and Calibration.

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

    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
    Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.

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