The Manager, Corporate CAPA manage the Global CAPA process across all the BA/SSU Getinge entities to ensure compliance with the Global CAPA process and provide general oversite to the local CAPA processes. Additionally, supports GetAligned Corporate activities, as required.
Manager, Corporate CAPA
Manage the investigation of Global CAPAs across all Getinge entities
Provide CAPA investigation expertise and oversight to the local CAPA teams
Manage CAPA Root Cause Investigation process to ensure utilization of six sigma and other applicable investigation tools for 26 BA sites and 10 SSU regional sites globally.
Manage Effectiveness Check process to ensure use of statistically sound / reliability principles and methodology
Support local / regional CAPA Governance meetings
Conducts Global CAPA process training, as required
Ensure the requirements for Global CAPA metrics (KPI) to Management Review are met
Support Global CAPA internal and external agency audits
Supports development, establishment, and maintaintenance of the GetAligned compliance activities for local sites and regions.
Conduct GetAlinged Procedures / Process trainings where required
Required Knowledge, Skills and Abilities:
Ten years related experience in a medical device manufacturing environment.
Must be a subject matter expert on the requirements of CAPA as described in the Quality System Regulation, 21 CFR Parts 820, Medical Device Directive and ISO 13485.
Experience responding to the FDA in writing and in person via audits.
Experience managing directly or indirectly CAPA teams in a fast-paced environment across multiple locations and countries.
Bachelor's Degree in Engineering, Chemistry or other related science discipline or equivalent combination of education and experience is required.
Minimum 10 years previous direct experience managing CAPA process.
5+ years related experience in a medical device manufacturing environment
We look forward to receiving your application. If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application. We hope you will join us on our journey to become the world's most desired medtech company.