Quality Assurance Manager
il y a 1 semaine
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International Candidate Manager │Medical DevicesOur customer is a fast-growing medical technology company focused on developing and marketing innovative solutions and services for a Class 3 medical device. As part of their expansion, we are looking for a QA Manager to join their team.
The post holder will be responsible for overseeing and managing the quality assurance and quality control programs for the organisation's Class 3 and other medical device products. This role ensures compliance with regulatory requirements, including FDA Quality System Regulations (QSR), ISO 13485 standards, and other global regulations and standards. The QA Manager leads the quality team in developing, implementing, and maintaining effective quality systems and processes to ensure the safety and efficacy of medical devices.
Key responsibilities:
- Develop, implement, and maintain a robust quality management system (QMS) following FDA QSR, ISO 13485, and other applicable global regulations and standards.
- Ensure the QMS is consistently applied across all phases of product development, manufacturing, and distribution.
- Conduct periodic audits and assessments to evaluate the effectiveness of the QMS and identify areas for improvement.
- Act as the Management Representative for the company site, as well as others as assigned.
- Maintain a thorough understanding of FDA regulations, ISO standards, and other applicable regulatory requirements for Class 3 and other medical devices.
- Establish and maintain comprehensive documentation systems, including device master records, design history files, and quality records.
- Develop and oversee risk management processes, including risk analysis, evaluation, and control measures.
- Investigate and manage non-conformances, complaints, and adverse events through an effective Corrective and Preventive Action (CAPA) system.
- Develop and deliver training programs to ensure all personnel are knowledgeable about quality practices and regulatory requirements.
- Establish and maintain supplier qualification and monitoring processes to ensure the quality of incoming materials and services.
To be considered for the role, you must closely match the following job profile:
- Medical device experience is a must.
- Bachelor's degree in a relevant field (e.g., engineering, science, quality management) or equivalent experience.
- Minimum of 5 years of experience in a quality assurance role within the medical device industry, experience with Class 3 devices is a plus.
- Solid knowledge of FDA QSR, ISO 13485, and other applicable global regulations and standards for medical devices.
- Strong leadership and interpersonal skills.
- Strong communication skills as well as able to explain complex topics in a clear, simple manner.
Mid-Senior level
Employment typeFull-time
Job functionQuality Assurance
IndustriesMedical Equipment Manufacturing, Hospitals and Health Care, and Biotechnology Research
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