What are the responsibilities and job description for the Quality Assurance Director position at QuidelOrtho?
We are seeking a highly skilled Quality Assurance Director to join our team at QuidelOrtho. In this role, you will be responsible for implementing and maintaining the quality management system in accordance with the Quality System Manual.
Job Description
The Senior Manager, Quality Assurance provides technical leadership, guidance, and support to the site in the areas of Quality Assurance and ensures compliance to all programs, procedures, applicable regulatory, and customer requirements as well as alignment with overall strategic objectives of the department and the business.
- Provides Quality functional leadership including hiring and managing a professional, high performing quality assurance staff designed to meet the technical and compliance requirements.
- Provides strategic planning and implementation for the Quality System, including Interpretation of MDSAP/ISO/IVD/USDA medical device regulations and guidelines to determine the impact to Quality Assurance Systems.
- Provides site guidance with respect to regulations, guidelines, and emerging inspectional trends.
Responsibilities
The Senior Manager, Quality Assurance is responsible for:
- Providing Quality functional leadership, including hiring and managing a professional, high performing quality assurance staff.
- Developing and implementing strategic plans for the Quality System.
- Providing site guidance on regulations, guidelines, and emerging inspectional trends.
- Ensuring compliance to all programs, procedures, applicable regulatory, and customer requirements.
Requirements
To be successful in this role, you will need:
- A BS/BA or equivalent work experience.
- Minimum of 7 years of progressively more responsible experience of quality system management in medical device and high-volume manufacturing environments.
- Extensive working knowledge of quality system requirements including ISO, MDSAP, IVD regulations.
Salary Information
The estimated salary range for this position is $120,000 - $150,000 per year, depending on experience.
QuidelOrtho offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
Salary : $120,000 - $150,000
