CAPA Project Leader

Manage CAPA activities including coordination/program management of overall CAPA system, CAPA Impact Analyses, and execution 
Monitor CAPA process timeliness and compliance within QMS in order to remain compliant 
Identify and report any quality or compliance concerns and take immediate corrective action as required 
Coach employees on CAPA process 
Establish strong operating mechanisms to track progress, identify issues, overcome obstacles, and define recovery plans 
Provide ongoing status reports to the business leadership team 
Collaborate with ECR program managers within Program Management Office (PMO) 
Work on additional ECR programs and projects as needed 

Requirements: 
Relevant BA/BS degree required. Advanced degree/MBA a plus 
Minimum 5 years of experience in medical device industry 
Minimum 5 years of experience applying regulations (including FDA QSR, ISO13485) 
Experience with CAPA process and implementation 
Ability to identify root cause of problem, and creatively problem-solve to gain resolution 
Project management certification (PMP) or equivalent desired; Agile experience (Scrum, SAFe) desired 
10+ years of functional and/or program management experience in a matrix environment, across multiple sites, and through the entire product lifecycle 
Strong people management skills, including: leadership, conflict resolution, negotiation and influence management 
Strong presentation and written skills, appropriate to both management and customer audiences 
Apply continuous improvement concepts, methodologies and deployment (Lean, Six Sigma) 
Ability to travel domestically (less than 10%). 

Thank you,
Sachin Patil,
510-574-7988
sachin@apninc.com

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