Director Global CAPA Programs
United StatesFull-TimeDirector
Salary183,000 - 210,000 USD per year
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Job Details
- Experience
- A minimum of 10 years related experience in a medical device quality process areas
- Required Skills
- Analytical SkillsComplianceMicrosoft Office Suite
Requirements
- Master’s Degree in a relevant field or equivalent combination of education and experience.
- Minimum of 10 years related experience in a medical device quality process areas.
- Subject matter knowledge in CAPA and NC processes.
- Strong understanding of Quality Management System operations and global regulations/ISO standards.
- High level of influence and mediation skills.
- Internal and External Audit Experience.
- Experience with consent decree and remediation activities.
- Strategic QMS thinker with excellent analytical and problem solving skills.
- Demonstrated ability to work collaboratively in a cross-functional, matrixed environment.
- General understanding of reporting tools (Crystal Reports, Power BI).
- Effective written and verbal communication, including technical writing skills.
- Proficiency with Microsoft Office Suite.
Responsibilities
- Lead cross functional teams to upgrade and improve performance of Getinge’s end-to-end CAPA System (NC and CAPA).
- Assesses health of system (compliance, efficiency, performance) and manages a portfolio of improvement projects.
- Support Getinge Entities in audit (internal and external) activities.
- Engage with stakeholders to ensure requirements are integrated into the CAPA system.
- Ensure compliance with the company’s Quality System policies and procedures.
- Conduct training sessions and workshops and serve as a CAPA coach.
- Participate in industry & FDA conferences to stay current on enforcement priorities.
- Develop and manage personnel.
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