Quality Management Systems Leader
1 week ago
Pursue a challenging career opportunity as a Quality Management Systems Leader with Prescott's, Inc., a premier medical device company committed to delivering high-quality and reliable products. As a member of our leadership team, you will be responsible for maintaining and enhancing the quality standards across all Prescott's operations.
This critical role involves developing comprehensive quality management systems, overseeing regulatory compliance, and fostering a culture of continuous improvement within the organization. You will lead the Quality Assurance team, providing direction and support in continuous improvement initiatives, and establish quality metrics and KPIs to monitor system effectiveness and drive improvements.
A bachelor's degree in engineering, life sciences, or a related field is required, with an advanced degree preferred. Relevant certifications such as ASQ CQE, CQA, RAC, or similar are highly desirable.
Salary: $123,000 per year, complemented by a 20% Manager's Incentive Plan.
About the Role:This is a unique opportunity to join a dynamic and fast-paced environment where you will be instrumental in shaping the company's strategic direction. As a Quality Management Systems Leader, you will be responsible for ensuring that Prescott's products meet both customer expectations and regulatory requirements while driving innovation and efficiency.
You will collaborate with cross-functional teams to identify quality issues and facilitate the resolution of non-conformance, and lead internal auditing activities as required by the Quality Management System. Your expertise in quality management systems, ISO standards, and FDA regulations will be invaluable in this role.
Responsibilities:- Develop and implement a comprehensive quality management system that aligns with company goals and regulatory requirements.
- Oversee the regulatory compliance framework, ensuring adherence to industry standards such as ISO 13485, FDA regulations, The Joint Commission, DNV, and other applicable legislation.
- Lead the Quality Assurance team, providing direction and support in continuous improvement initiatives.
- Establish quality metrics and key performance indicators (KPIs) to monitor system effectiveness and drive improvements.
- Collaborate with cross-functional teams to identify quality issues and facilitate the resolution of non-conformance.
- Bachelor's degree in engineering, life sciences, or a related field; advanced degree (MBA or MS) preferred.
- 10+ years of experience in quality assurance and regulatory compliance role, with at least 5+ years in a leadership position.
- In-depth knowledge of quality management systems, ISO standards, and FDA regulations.
- Relevant certifications such as ASQ CQE, CQA, RAC, or similar are highly desirable.
- Experience with QMS implementation and management.
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