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