Posted Jun 07, 2024 294 views
We are seeking a dedicated and experienced Quality Assurance Manager / Manager Representative to join our team. The ideal candidate will have a strong background in Quality Management Systems (QMS) and the ability to lead a team to ensure compliance with industry standards. Experience in the surgical industry and knowledge of technical drawings management systems is preferred.
Key Responsibilities:
- Oversee and manage the Quality Management System (QMS) to ensure it meets industry standards and regulatory requirements.
- Lead and coordinate a team of quality assurance professionals.
- Maintain and manage technical drawings and related management systems.
- Conduct internal and external audits to ensure compliance with ISO 18435 and other relevant standards.
- Ensure compliance with Medical Device Regulation (MDR) and Unique Device Identification (UDI) requirements.
- Develop, implement, and monitor quality control systems to ensure product quality and compliance.
- Identify and address quality issues and implement corrective actions.
- Provide training and support to staff on quality management systems and standards.
Qualifications and Experience:
- Minimum of a Bachelor's degree in Engineering or a related field; a Master’s degree is preferred.
- 8 to 10 years of experience in quality assurance, with a preference for experience in the surgical industry.
- In-depth knowledge of Quality Management Systems (QMS).
- Familiarity with ISO 13485 standards.
- Experience with Medical Device Regulation (MDR) and Unique Device Identification (UDI) requirements.
- Proven experience in conducting internal and external audits.
- Strong leadership and team management skills.
- Excellent communication and problem-solving abilities.
Skills
Job Details
B&H Surgical Instrument
B&H Surgical Instrument
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