CAPA Expert/Quality Engineer

As a CAPA Engineer in our Quality & Regulatory organization supporting the Magnetic Resonance Imaging business (MRI), you play a crucial role in driving Corrective and Preventive Action (CAPA) activities. From identifying issues to closure, you will project manage all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.

Location: Pune

Contract: 1 year (Extendable)

Key Responsibilities:

• Support the entire CAPA process, from assessing complex investigations to implementing corrective actions.

• Lead complex root cause analysis and quality problem-solving efforts.

• Facilitate product and process CAPA investigations, guiding the team from issue identification to solution implementation and effectiveness monitoring.

• Collaborate with CAPA Owners to secure cross-functional resources, schedule team meetings, and meet project timelines.

• Mentor cross-functional teams in implementing root cause analysis techniques and analyzing quality monitoring data.

• Apply statistical techniques to identify existing and potential causes of non-conformances.

• Ensure compliance with global regulations, including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.

• Utilize a customer-first attitude and leverage a B.Sc in Engineering or a related field, with advanced degrees being advantageous.

Qualifications:

• Bring 5 years of experience in quality roles in the medical device industry.

• Working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971. Good understanding of statistical methods, quality tools, problem-solving tools, and methodologies (i.e. 8D, DMAIC, SPC, FMEA, Control Plan, LEAN).

• Strong in technical writing.

• Experience in driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings

• Serve as a team facilitator/team coach with experience in complex organizational environments.

• Possess strong communication and interpersonal skills to effectively coach teams in a matrix environment.

Apply now to be a part of our journey towards a better tomorrow. You can reach out to me in case of any questions or you can email me at Pallavi.mahadik_1@philips.com.