Quality Assurance Manager for Medical Devices
3 weeks ago
Automationtechies is seeking a highly skilled Quality Assurance Manager to lead our medical device quality initiatives. This role will be responsible for managing and implementing our Quality Management System (QMS) to ensure compliance with cGMP, ISO 13485, and other applicable standards.
The ideal candidate will have experience in managing quality systems, implementing and leading internal and external audits, and developing and implementing manufacturing standard operating procedures (SOPs). They will also be responsible for establishing and managing safety and regulatory requirements for equipment, facility, and personnel.
Key responsibilities will include:
- Managing and implementing QMS and compliance with cGMP, ISO 13485, and other applicable standards
- Developing and implementing manufacturing SOPs, policies, procedures, tools, and templates
- Establishing, training, and managing safety and regulatory requirements for equipment, facility, and personnel
- Providing additional expertise and assistance in production operations, safety, customer service, etc.
The successful candidate will have a strong background in quality engineering and management, with experience in medical devices or components sold into medical devices. They will also have excellent communication and presentation skills, with the ability to work effectively within a high-caliber team and influence others.
Automationtechies offers a fast-paced and dynamic work environment, with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality and excellence, we encourage you to apply for this exciting opportunity.
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