QA Manager

1. Required: Bachelor s degree in engineering life sciences or a related field. Common degrees include Biomedical Engineering Mechanical Engineering or Biochemistry.
2. Preferred: Advanced Degree (Master s or higher) in a specialized field or for higherlevel positions.

1. Industry Experience: 510 years in the medical device industry with a focus on quality assurance quality control or regulatory affairs.
2. Management Experience: 35 years in a managerial or supervisory role overseeing QA teams and processes.
3. Regulatory Knowledge: Extensive experience with regulatory requirements such as ISO 13485 and other relevant standards.

1. Quality Management Systems (QMS): Indepth knowledge and experience in implementing and maintaining QMS.
2. Auditing: Experience in conducting internal and external audits including supplier audits.
3. ProblemSolving: Strong analytical skills for addressing quality issues and implementing corrective and preventive actions (CAPA).
4. Documentation: Proficiency in developing reviewing and managing qualityrelated documentation.
5. Communication: Excellent skills for coordinating with crossfunctional teams senior management and regulatory bodies.
6. Attention to Detail: High attention to detail to ensure compliance and product quality.
7. Leadership: Strong leadership skills to effectively manage and mentor QA team members.
8. Language Skills: Fluent in verbal and written English.

• Corrective and Preventive Actions (CAPA): Implement and manage CAPA processes to address product and process nonconformities.

• Supplier Quality Management:

1. Supplier Evaluation: Evaluate and approve suppliers conduct supplier audits and monitor supplier performance.
2. Incoming Inspection: Ensure the quality of incoming materials through inspection and testing.

• Continuous Improvement:

1. Process Improvement: Identify and implement process improvements to enhance quality and efficiency.
2. Training and Development: Provide training on quality policies procedures and regulatory requirements.

• Complaint Handling and PostMarket Surveillance:

1. Complaint Investigation: Manage the investigation of customer complaints and ensure timely resolution.
2. PostMarket Surveillance: Oversee activities to monitor product performance and safety in the field.

• Team Leadership:

1. Team Management: Lead and mentor the QA team providing guidance and support
2. CrossFunctional Collaboration: Work with other departments (e.g. R&D manufacturing regulatory affairs) to ensure quality objectives are met.

• Reporting:

1. Quality Metrics: Develop and track key quality metrics and generate regular reports for senior management.
2. Management Reviews: Conduct reviews to evaluate the effectiveness of the QMS and identify areas for improvement.

documentation,problem-solving,cross-functional collaboration,continuous improvement,reporting,complaint handling and post-market surveillance,regulatory affairs,iso standards,management reviews,training and development,leadership,auditing,quality assurance,quality management systems (qms),team leadership,supplier quality management,quality control,total quality management (tqm),quality auditing,communication