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Quality Assurance Leader
3 weeks ago
Quality Assurance Leader
About the Role:
The Quality Assurance Leader will be responsible for overseeing the development and maintenance of our company's Quality Management System (QMS). This includes implementing existing and new ISO 13485 and GxP regulations, as well as other relevant standards. The ideal candidate will have a strong understanding of quality management principles and experience in leading QA teams.
Responsibilities:
- Develop and implement QMS processes and procedures.
- Liaise with regulatory bodies and internal stakeholders to ensure compliance with local and international regulations.
- Conduct internal audits and implement corrective actions.
- Manage external audits from customers, suppliers, and regulatory bodies.
- Coordinate site inspections and handle complaints, recalls, deviations, and CAPAs.
- Track and report quality-related KPIs and objectives.
Requirements:
- Bachelor's degree in quality management, life sciences, engineering, or a related field.
- Minimum 3 years of QA experience in ISO 9001, ISO 13485, or GxP.
- Strong analytical and problem-solving skills.
- Excellent communication and leadership skills.
- Familiarity with risk management principles and quality improvement methodologies.
Preferred Qualifications:
- Lead auditor qualification in ISO 9001, ISO 13485.
- Quality management certifications such as CQA or CQM.
What We Offer:
A competitive salary and benefits package. Opportunities for professional growth and development. A dynamic and supportive work environment.
