
Senior Quality Systems Specialist
2 days ago
We are seeking a Quality Assurance Manager to oversee the implementation and maintenance of our quality management system.
- Responsibilities include controlling and ensuring compliance with ISO 9001, ISO 13485, and CGMP standards.
The successful candidate will be responsible for establishing, maintaining, and improving our quality management system, performing final inspections and in-process inspections as required.
Collaboration with the R&D department to develop new products and processes is also a key aspect of this role.
Maintenance of calibration records and performance of calibrations as necessary, issuance of corrective action plans (CAPAs) in response to customer complaints, and preparation of agendas and minutes for quality control meetings are additional responsibilities.
Providing training to employees on quality management practices and effectively managing customer complaints and resolving issues are also essential tasks.
The successful candidate must ensure accurate documentation and data control, as well as preparation of certificates of conformance and other quality-related documents.
Key Responsibilities- To implement and maintain the Quality Assurance System.
- Ensure compliance with regulatory requirements and industry standards.
- Bachelor of Science in Mechanical Engineering or related field.
- At least 2 years' experience in a quality assurance role, preferably in the surgical industry.
- Strong technical skills, including computer operation and mathematical abilities.
- Excellent English language comprehension and communication skills.
- Able to work independently and as part of a team.
- Master's degree in a related field.
- Experience working in a regulated environment.
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