Vacancy for CAPA specialist at Philips
Insight:
Philips is recruiting an experienced CAPA specialist at its Pune site.
The complete details of this work are as follows:-
Roles and responsibilities:
The ideal candidate must be able to:
Be a key ambassador in promoting a culture of quality and excellence at Philips
Support the receipt of CAPA requests from power processes, working with initiators to refine the problem description to present to the CRB
Support CAPA activities: Evaluate complex investigations and corrective actions, review testing and other complex performance data, lead complex root cause analysis and resolution of quality issues
Facilitate product and process CAPA investigations, from problem identification to solution implementation and effectiveness tracking
Ensure CAPA KPIs are achieved
Support the CAPA Owner in all aspects of the CAPA activity, which includes securing cross-functional resource engagement, scheduling CAPA team meetings, and ensuring CAPA deliverables on project timelines
Support CAPA owners in presenting CAPAs during audits and CAPA review committee meetings
Coach cross-functional teams with the implementation of appropriate root cause analysis techniques
Supervise the analysis of quality monitoring data sources and apply statistical techniques to identify existing and potential causes of nonconformities
Eligibility:
Engineering or other relevant university degree in statistics, quality management, etc., higher degrees – an advantage
5+ years of experience in quality roles in medical device or other regulated industries
Working knowledge of relevant global regulations, requirements and standards such as 21 CFR Parts 820, ISO 13485 or ISO 9001 and ISO 14971
Good understanding of statistical methods, quality tools and methodologies (i.e. 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) – an advantage
Experience as a team facilitator / team coach
Experience working in complex organizations with manufacturing, R&D and engineering environments
Strong communication and interpersonal skills, ability to coach teams in cross-functional teams in a matrix environment
Ability to creatively solve complex problems and influence stakeholders accordingly
Multitasking and decision-making skills
Autonomous, motivated, action-oriented
Experience working in a global corporate environment
Fluent English
Influential Skills
Basic project management skills
Critical Thinking Skills
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