Senior CAPA Specialist
Senior CAPA Specialist
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Job Description
Stryker is hiring a Senior CAPA Specialist in Portage MI within the Instruments division! In this role youll lead the execution of the Divisional Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes ensuring quality issues are addressed effectively and in compliance with global standards. Leveraging your expertise in problem-solving methodologies youll help drive proactive issue resolution and continuous improvement across the organization.
Workplace Flexibility: Candidate must reside within a commutable distance to Portage MI but is expected to be onsite at the facility multiple times/week.
What you will do-
- Support post-market quality activities by reviewing and approving Nonconformances (NCs) and Corrective and Preventive Actions (CAPAs) for completeness accuracy and compliance with FDA ISO 13485 and global regulatory standards.
- Assist in developing and delivering training for CAPA users promoting understanding of system requirements problem-solving methodologies (e.g. 4D) and best practices.
- Collaborate with cross-functional teams to resolve quality issues integrate processes from acquisitions and maintain documentation such as business process maps and SOPs.
- Contribute to continuous improvement initiatives by assessing NC/CAPA records identifying trends and supporting enhancements to procedures and systems.
- Participate in internal corporate and external audits by preparing documentation and supporting discussions related to NC/CAPA processes and records.
- Monitor and present NC/CAPA metrics to leadership helping drive achievement of key performance indicators (KPIs) and process effectiveness.
- Facilitate CAPA boards and specialist meetings supporting alignment across departments and ensuring timely and rigorous documentation in the eCAPA system.
- Act as a resource for CAPA record owners and stakeholders providing guidance on regulatory expectations documentation standards and system navigation.
What you need:
Required:
- Bachelors degree in a Science or Engineering required.
- Minimum 2 years of experience in quality systems or engineering with exposure to CAPA processes and supporting quality system elements such as audits management review and quality planning.
- Experience working in regulated environments and supporting interactions with regulatory agencies (e.g. FDA TUV BSI) required.
Preferred:
- Working knowledge of U.S. FDA regulations and international standards (e.g. ISO 13485 EU MDR) with the ability to interpret and apply regulatory requirements in a practical setting.
Required Experience:
Senior IC
Employment Type
Full-Time
