Quality Assurance Director
6 days ago
We are seeking a highly experienced Quality Manager to join our team at CorDx in San Diego. This is an onsite position with a competitive salary range of $100,000- $130,000.
The ideal candidate will have a minimum of 10 years of experience in the medical device industry, with a strong background in quality management, regulatory compliance, and ISO standards.
About the Role- Develop and implement effective quality control processes to ensure products meet customer requirements and legal standards.
- Devise and review specifications for products or processes, setting requirements for raw materials and monitoring supplier compliance.
- Supervise inspectors, technicians, and other staff, providing guidance and feedback to maintain high-quality standards.
- Oversee product development procedures to identify deviations from quality standards and inspect final output for adherence to requirements.
- Approve products that meet standards and reject defectives, maintaining accurate documentation and performing statistical analysis.
- Minimum Bachelor's degree in Science or related field.
- ISO 13485:2016 lead auditor certification preferred.
- Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
- Strong understanding of quality management principles and practices in the medical device industry.
- Excellent communication and interpersonal skills, with ability to work collaboratively in a team environment.
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
We celebrate diversity and recognize that it builds stronger teams. We approach diversity and inclusion seriously and thoughtfully, ensuring a welcoming and inclusive work environment for all employees.
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