Senior Quality Assurance Manager

Take the responsibility of Quality Assurance for the Medical industry.

Contribute to strategic planning and decision making at the top executive level so that the company is aligned with the vision, mission, and long-term objectives of the corporate organization.

Develop and implement quality systems together with quality control programs to achieve the objectives of high quality of products and quality systems.

Main Responsibilities and Authority

1. Assume the responsibility for quality system management representative and the responsible engineering manager.
2. Establish general quality strategy of the company and determine the quality policy and objectives.
3. Establish, implement, and improve the quality management system. Set quality standards and related quality system documentation and control of implementation.
4. Oversee the operation of the QA team to ensure the product quality meets requirements of medical device regulatory, company policy, and customers’ procedure requirements.
5. Establish and optimize the inspection standards of incoming, process control, and finished goods, and monitor performance.
6. Establish processes to ensure the final device conforms to regulatory requirements and specifications, driving improvements through findings.
7. Drive improvements through customer complaints.
8. Approve department-related quality system documents and the closure of quality system nonconformities.
9. Approve closure of CAPA related to product quality.
10. Continuously contribute, develop, and implement ideas that improve performance.
11. Proactively join in supplier quality performance management, collaborating with engineering and procurement departments to assess suppliers.
12. Handle internal and external customer complaints, communicating with customers and quality control on quality and related issues.
13. Conduct internal quality audits, initiate and participate in management reviews.
14. Provide essential and basic skill training for the quality department and enhance the quality concept of employees in the organization.
15. Follow customer/external audits.
16. Professionalize all quality systems and people, moving from inspecting quality into design and process quality.
17. Develop and implement document control programs, interface with global customers, and design and implement vendor programs for quality systems.
18. Provide customers globally with quality service to support sales and marketing.
19. Maintain and develop quality systems.
20. Ensure implementation and adherence to Health, Safety & Environmental (HSE) procedures in areas of responsibility.

Qualifications

Education: Diploma / Bachelor and above, major in Engineering or Science.

Working Experience: Above 10 years of related management experience.

Professional Requirements

1. Strong ability in production procedures and quality control.
2. Leadership skills and strong business sense.
3. Familiar with electronic production procedures.
4. Strong data analytical and problem-solving skills.
5. Fluent in both oral and written English; computer skills.
6. Familiarity with FDA QSR Part 820 (Class 1 and Class II Medical Devices).
7. Knowledge of Medical Device Single Audit Program (MDSAP).
8. ISO13485 (current version).
9. Medical Device Act 2012 (Act 737).

Other Requirements

1. High responsibility.
2. Good team player.
3. Good personality.
4. Good summary and presentation skills.
5. Systematic and global mindset.
6. Good communication skills.