
Strategic Quality Assurance Leader
1 day ago
Job Description:
We are seeking a highly experienced and skilled Strategic Quality Assurance Leader to join our organization. In this role, you will be responsible for providing strategic leadership and direction to ensure the quality of our products and services.
- Develop and implement QA strategies aligned with business goals
- Lead cross-functional teams to ensure quality and regulatory compliance throughout the product lifecycle
- Represent the company in regulatory and quality discussions with external stakeholders, including regulatory bodies, partners, and auditors
Key Responsibilities:
- Oversee the Quality Management System (QMS) ensuring compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, GDP, and GVP standards
- Lead internal and external audits, inspections, and quality improvement initiatives
- Manage CAPA (Corrective and Preventive Actions), non-conformance, and complaint handling processes
- Ensure validation of equipment, processes, and software used in manufacturing and testing
Requirements:
- Master's degree in Pharmacy, Chemistry, Biotechnology, Biomedical Engineering, or related field
- Minimum 15 years of experience in QA and RA, with at least 5 years in a leadership role in the medical device or pharmaceutical industry
- Proven expertise in ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, GDP, and GVP
Benefits:
- Opportunity to work with a dynamic team
- Professional growth and development opportunities
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