Quality Analyst - FDA Regulated Manufacturing at Mayo Career Site US

Rochester, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Sep, 26

Salary

117312.0

Posted On

23 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Regulatory Compliance, FDA GMPs, ISO Certification, Project Management, Analytical Thinking, Critical Thinking, Communication Skills, Audit Management, Documentation Practices, SOP Development, Risk Reduction, Leadership, Professionalism, Objectivity, Change Management

Industry

Hospitals and Health Care

Description

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.). Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans [https://jobs.mayoclinic.org/benefits/] – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. Benefits Highlights * 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. Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. [https://jobs.mayoclinic.org/alllocations] Equal Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" [https://www.eeoc.gov/poster]. Mayo Clinic participates in E-Verify [https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf] and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.

Responsibilities

The Quality Analyst is responsible for implementing quality and regulatory compliance for product manufacturing activities to reduce risk. They manage the Quality Management System (QMS) and serve as a subject matter expert for various manufactured products like medical devices and cellular therapies.