Chief Quality Assurance Officer
2 weeks ago
We are seeking a highly skilled Quality Assurance Specialist to join our team.
Job Responsibilities:- Implement and maintain a Quality Management System (QMS) to ensure compliance with regulatory requirements.
- Ensure adherence to medical device regulations for market entry and ongoing compliance, including identifying and interpreting key regulations.
- Manage documentation, including creating, reviewing, and controlling technical files, regulatory submissions, and internal procedures.
- Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
- Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Monitor device performance in the market, investigate customer complaints, and manage vigilance reporting.
- Support the management of supplier quality and compliance.
- Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
- Deep knowledge of global medical device regulations and standards.
- Strong problem-solving skills and attention to detail.
- Effective 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.
- Previous experience in QA/RA within the medical device industry is an advantage.
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