CAPA Engineer

CAPA Engineer

Location: Best

Duration Assignment: 6 months (with possible extension and/or Philips transfer in time)

Contract: Via a Randstad company

In this role, you will have the opportunity to support the Corrective and Preventive Action (CAPA) process from issue identification to closure and ensure adequate execution of the process and the quality of CAPA record content. You will be part of our Quality & Regulatory organization, supporting Image Guided Therapy Systems.

Key Responsibilities:

• Support CAPA Activities:

  • Assess complex investigations and corrective actions.

  • Review test and performance data.

  • Lead root cause analysis and quality problem-solving.

• Facilitate CAPA Investigations:

  • Manage investigations from issue identification through solution implementation and effectiveness monitoring.

  • Assist CAPA Owners with securing cross-functional resources and scheduling team meetings.

  • Ensure CAPA deliverables are met according to project timelines.

• Audit Support:

  • Assist CAPA Owners in presenting CAPAs during audits and Review Board meetings.

• Mentorship:

  • Mentor cross-functional teams on root cause analysis techniques.

  • Guide the analysis of quality monitoring data and apply statistical methods to identify causes of non-conformances.

Experience & Skills required to perform this role better:

• Educational Background:

  • B.Sc in Engineering or a related field (Statistics, Quality Management, etc.) with a minimum 5+ years in quality roles within the medical device or other regulated industries.

  • Familiarity with global regulations and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.

  • Proficient in statistical methods and quality tools (8D, DMAIC, SPC, FMEA, Control Plan, LEAN).

  • Experience as a team facilitator/coach.

  • Strong communication and interpersonal skills.

  • Ability to resolve complex issues creatively and influence stakeholders.

  • Effective multi-tasking and decision-making capabilities.

  • Experience in a global corporate environment.

Interested candidates are encouraged to apply with their resume with their relevant experience before June 3rd ! In case of queries/information needed, you can reach out to me via email, Pallavi.mahadik_1@philips.com.