Quality Assurance Strategist
4 weeks ago
CorDx is a leading biotech organization dedicated to delivering innovative diagnostic solutions. We are seeking a highly skilled Quality Assurance Strategist to join our team.
The successful candidate will be responsible for developing and implementing quality assurance strategies to ensure compliance with FDA, ISO 13485, and other relevant regulatory requirements. This includes leading and mentoring the quality assurance team, fostering a culture of continuous improvement and accountability.
The ideal candidate will have a strong background in quality management, with a proven track record of successfully managing a quality assurance team in a regulated environment. They will also possess excellent analytical, problem-solving, and decision-making skills, as well as strong communication and interpersonal skills.
Key Responsibilities:
- Develop and implement quality assurance strategies to ensure compliance with regulatory requirements.
- Lead and mentor the quality assurance team.
- Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and lifecycle management.
- Oversee the maintenance and continuous improvement of the company's QMS.
Requirements:
- Master's degree in a scientific or engineering discipline.
- Minimum of 10 years of experience in quality assurance within the IVD Class II devices manufacturing industry.
- Extensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
Benefits:
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
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