
Quality Assurance Manager
3 days ago
We are seeking an experienced Quality Assurance and Regulatory Affairs professional to develop and implement a comprehensive quality management system that meets regulatory requirements.
The successful candidate will be responsible for:
- Developing and implementing a quality management system that meets ISO 9001:2008, ISO 13485, and FDA's 21CFR, Section 820 (GMP) quality system regulation requirements
- Training staff on quality procedures and protocols
- Conducting audits and ensuring compliance with ISO 9001:2008/ISO 13485
- Leading by example and demonstrating strong leadership qualities
Key Requirements Include:
- Master's degree in Total Quality Management or related field
- 5 years' experience in system development, implementation, and audit of ISO 9001:2008/ISO 13485
- Lead auditor certification for ISO 9001:2008/ISO 13485
- Excellent IT skills and strong analytical abilities
What We Offer:
- A competitive compensation package based on qualifications and experience
- Opportunities for professional growth and development
- A dynamic and supportive work environment
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