Quality Analyst - FDA Regulated Manufacturing
About The Position
The Quality Analyst, FDA Regulated Manufacturing is responsible for implementation of quality and regulatory compliance for product manufacturing activities. The Quality Analyst directs the work to identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems. Is accountable for the effective implementation of the Quality Management System (QMS) and serves as the local subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing. This position may be required to take direction from management staff across multiple departments and develop expertise in multiple types of products manufactured at Mayo Clinic (i.e., medical devices, tissues, cellular therapies, etc.).
Requirements
- FDA Regulated Manufacturing experience
- Knowledge of Quality Management System (QMS)
- Ability to develop expertise in multiple types of products manufactured at Mayo Clinic (i.e., medical devices, tissues, cellular therapies, etc.)
Responsibilities
- Implementation of quality and regulatory compliance for product manufacturing activities.
- Identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices.
- Ensure compliance is built into the operational systems.
- Effective implementation of the Quality Management System (QMS).
- Serve as the local subject matter expert on the policies, processes and procedures of the QMS.
- Develop a broad knowledge of the practice, business and technology as it relates to product manufacturing.
- May be required to take direction from management staff across multiple departments.
- Develop expertise in multiple types of products manufactured at Mayo Clinic (i.e., medical devices, tissues, cellular therapies, etc.).
Benefits
- Competitive compensation
- Comprehensive benefit plans
- Medical: Multiple plan options.
- Dental: Delta Dental or reimbursement account for flexible coverage.
- Vision: Affordable plan with national network.
- Pre-Tax Savings: HSA and FSAs for eligible expenses.
- Retirement: Competitive retirement package to secure your future.
- Continuing education and advancement opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
