CAPA Engineer

Philips Electronics North America-posted 9 months ago
$87,000 - $140,000/Yr
Full-time • Mid Level
Onsite • San Diego, CA
Computer and Electronic Product Manufacturing
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In this role you Develop project management, leadership and interpersonal skills by driving CAPA activities and CAPA process improvements for Philips' Image Guided Therapy Device (PIGT-D) business unit. The role will be responsible for working with individual CAPA owners to ensure effective, timely CAPA completion and regularly providing process insights to upper leadership as well as focusing on individual career growth.

  • Facilitating product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
  • Project managing all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
  • Representing CAPAs during audits and CAPA Review Board meetings.
  • Leading and mentoring cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
  • Performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
  • Bachelor's degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence.
  • Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971.
  • 3+ years of related experience in medical device or other regulated industry.
  • Strong Project Management skills, including ability to project manage all CAPA activities.
  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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