Senior Quality Assurance Manager
1 day ago
This role involves managing the overall quality management system to ensure products adhere to safety, regulatory standards and quality requirements.
- Key Responsibilities
- Establish and maintain a comprehensive quality management system that ensures adherence to relevant medical device regulations for market entry and ongoing compliance.
- Develop and implement procedures for documentation management, design control, risk management, post-market surveillance, and supplier management.
- Collaborate with cross-functional teams to identify and mitigate potential hazards throughout the product life cycle.
- Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
- Required Skills & Qualifications
- Regulatory Expertise
- Deep understanding of global medical device regulations and standards.
- Problem-Solving & Attention to Detail
- Crucial for interpreting regulations, documenting processes, and resolving issues.
- Communication Skills
- To coordinate with internal departments and external stakeholders.
- Bachelor's Degree
- In a relevant field such as engineering, life sciences, or a related technical discipline.
- Experience
- Previous experience in QA/RA within the medical device industry is an advantage.
- Regulatory Expertise
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