Medical Device Quality Assurance Professional
1 day ago
The role of the Senior Quality Assurance Lead is instrumental in ensuring the highest standards of quality, safety, and regulatory compliance for medical devices. This position requires a skilled professional who can implement and maintain an effective Quality Management System (QMS) to meet international standards.
Key Responsibilities:- Establish and oversee the implementation of a robust QMS to guarantee products adhere to quality, safety, and regulatory requirements.
- Interpret and apply relevant medical device regulations to ensure market entry and ongoing compliance.
- Develop, review, and manage technical files, regulatory submissions, quality agreements, and internal procedures.
- Collaborate with design and development teams to ensure QA/RA input and support for compliance from the outset.
- Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
- Monitor device performance, investigate customer complaints and non-conformity, and manage vigilance reporting.
- Oversee supplier quality and compliance management.
- Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.
- Deep understanding of global medical device regulations and standards.
- Strong problem-solving and attention to detail skills for interpreting regulations, documenting processes, and resolving issues.
- Effective communication and coordination skills for working 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 highly beneficial.
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