Location: N/A
Job Summary:
Job Duties and Scopes
- Enforce and harmonize quality systems across business sites.
- Manage compliance with FDA regulations and ensure product safety.
- Interact with stakeholders for product development guidance.
- Monitor product safety risk management performance and report KPIs.
- Conduct detailed quality engineering tasks and support post-market processes.
- Identify process improvement opportunities through analysis.
Required Skills
- Experience in Quality Management and Risk Management.
- Knowledge of medical device industry standards (ISO 13485, ISO 14971).
- Proficiency in Corrective and Preventive Actions (CAPAs) and audits.
- Strong collaboration and regulatory compliance skills.
- Ability to influence decisions and demonstrate accountability.
Required Experiences
- 10+ years in Quality Management and Risk Management.
- Proven leadership in audits and decision-making independence.
- Relevant scientific or engineering bachelor's degree preferred (or equivalent experience).
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