Demo

Senior Quality Engineer

Philips
Colorado, CO Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/7/2025

Job Title

Senior Quality Engineer

Job Description

The Senior Quality Engineer will play an important role within Philips' Image Guided Therapy Devices (IGTD) organization, providing Quality Engineering leadership in developing, establishing and maintaining quality engineering methodologies, systems, and practices, which meet Internal and FDA / Notified body compliance standards.

Your role :

  • Responsible for ensuring compliance with Philips Image Guided Therapy Devices (IGTD) procedures and applicable compliance standards / regulations and investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Will ensure Risk Management (ISO 14971) is effective, utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Leads problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
  • Responsible for leading and supporting Test Method Validations (TMV) plans / protocols / reports, Complaint Investigations / Health Hazard Analysis (HHAs) to ensure risk assessment and root cause analysis are consistent across products and systems.
  • Responsible for developing validation strategies, ensuring all appropriate requirements are met from planning, protocol definition, leading execution of protocols, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close.
  • Participates in the development and results analysis of validation plans (IQ / OQ / PQ) and test protocols to qualify and validate existing product designs / processes and supports Non-Conformance Reporting (NCR) Lifecycle.
  • Will determine and recommend sampling plans, equipment requirements, measurement techniques and training requirements that will ensure specific quality levels. Leads the non-conforming material process and participate in or leads the Materials Review Board.

You're the right fit if :

  • You've acquired a minimum of 7 years' experience in Quality Engineering roles within FDA regulated medical device environments, with the ability to lead critical Quality Engineering initiatives and strong understanding in Risk Management-ISO 14971.
  • You have proven experience in leading problem-solving, Root Cause Analysis, Statistical Techniques / analysis (DOE, Minitab) / JMP software preferred) and related Corrective and Preventive Actions (CAPA). Experienced with measuring tools and troubleshooting equipment.
  • You have proven expertise in inspection / testing techniques, Medical Device Design controls, defining Design inputs, outputs, specifications, acceptable quality levels and able to write / review Design verification plans / protocols and reports.
  • You have experience in Audit / Audit Support, with detailed knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO13485, ISO14971, EUMDR for all classifications of medical devices.
  • You have the ability to drive projects, make strategic decisions, collaborate / interface cross-functionally with R&D / Manufacturing Engineering, as well as other disciplines, and the proven ability to effectively communicate / build relationships with internal / external stakeholders at all levels of the organization.
  • You have a minimum of a Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Process / Quality Engineering, Analytical Chemistry, or related technical discipline (REQUIRED).
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
  • How we work together :

    We believe that we are better together than apart. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role.

    About Philips :

    We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

  • Learn more about our business .
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Learn more about our commitment to diversity and inclusion.
  • Philips Transparency Details :

  • The pay range for this position in Colorado Springs, CO is $114,000 to $183,000.
  • The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge / skills, experience, business needs, geographical location, and internal equity.

    In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .

    At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

    Additional Information

  • This role may require travel up to 10%.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
  • Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO.
  • LI-PH1
  • This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

    Philips is an Equal Employment and Opportunity Employer / Disabled / Veteran and maintains a drug-free workplace.

    PDN-9e5924cf-7fba-4ad1-b587-fa0937ac37c4

    Salary : $114,000 - $183,000

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