
Senior Quality Assurance Lead
3 days ago
We are currently seeking an experienced Senior Quality Assurance Lead to join our global team at Maxwill International.
The ideal candidate will have a strong background in quality management systems, regulatory compliance, and team leadership.
The main responsibilities of this role include:
- To establish and maintain a quality management system that meets the company's objectives.
- To conduct regular audits to ensure the quality management system is operating effectively.
- To develop and implement quality procedures, ensuring they are approved and effectively used by all staff members.
- To verify that measurement and inspection equipment is calibrated regularly to ensure product quality meets specified standards.
- To analyze quality control data on a periodic basis, identifying trends and areas for improvement.
- To manage the distribution and update of quality documents, preventing the reuse of obsolete materials.
- To initiate corrective actions when necessary, collaborating with other departments to address quality issues.
- To maintain records of calibration for quality control devices, adhering to established schedules.
- To participate in supplier evaluations and foster relationships with external organizations related to quality assurance.
- To lead internal audit teams, prepare annual audit plans, and ensure continuous communication of results.
- To promote occupational health and safety awareness among employees, ensuring adherence to relevant regulations.
- To take swift action to resolve non-compliance issues with medical devices and products supplied to the market.
The ideal candidate will possess:
- A bachelor's degree in a relevant field.
- A minimum of 12 years of experience in quality management, with team leadership skills.
- Advanced English language proficiency (written and spoken).
- Familiarity with Microsoft Office and Logos software.
- Knowledge of MDR, MDD processes, and FDA regulations.
- Mastery of ISO 13485 certification processes.
- Strong analytical thinking, problem-solving, and time management skills.
This is an excellent opportunity for a qualified professional to contribute their expertise to our team at Maxwill International.
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