Find & Apply For Quality Control Systems Manager Jobs in Rochester, Minnesota

Come work with RION in the heart of downtown Rochester, a vibrant rapidly-growing city located in Southeast Minnesota. Located in the home of the number one hospital in the country, time and again, Rochester, MN, ranks among the best places to live in the United States owing to its affordable cost of living, healthy lifestyle, stellar school systems, and exceptional quality of life. Rochester is also well known as a global destination for health and wellness. For the past decade, state officials in collaboration with the Mayo Clinic and City of Rochester, have implemented Destination Medical Center, a 20-year, $5.6 billion economic development initiative focused on developing Rochester as a global epicenter for life sciences and healthcare innovation. Utilizing public and private investments, Rochester is creating an inviting ecosystem for biotechnology start-up ventures looking to capitalize on a skilled and educated workforce.

MISSION AND VISION

Re-Imagining Medicine We seek to change the approach to regenerative medicine by utilizing exosome technology to improve the lives of more patients, in more places, across more diseases, from every walk of life. Quality systems manager, Aesthetics Quality Operations About Rion Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion's mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women's health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world. Position Summary Rion is recruiting a highly motivated quality leader to help advance its manufacturing of commercial cosmetic products. The ideal candidate will contribute to our goals of growing our manufacturing capabilities and expanding our aesthetic product portfolio. The Quality Systems Manager will be responsible for owning and continuously improving Rion's Quality Management System, including supplier quality, audits, and EQMS administration, training, change control, investigations, CAPA, and quality metrics in support of aesthetic product manufacturing. Reporting to the site lead, the candidate will:

Job Responsibilities:

Maintains, expands, and matures all aspects of the quality systems supporting Rion's aesthetics manufacturing vertical Ensure compliance with FDA, ISO, and other regulatory requirements Collaborates with the manufacturing and development teams to grow the product portfolio Resolves issues that arise to ensure a consistent supply of product with a focus on continuous improvement Grows Rion's quality culture emphasizing the importance of quality to Rion's customers Maintains effective quality relationships with all existing Rion raw material suppliers, contract testing laboratories, and contract manufacturing organizations Develop and execute the annual supplier audit strategy. Onboards, audits, and qualifies new suppliers Performs surveillance audits of suppliers and maintains the approved supplier list Uses risk-based approach to supplier oversight, issues quality agreements with critical suppliers Collaborates with suppliers when issues arise, issues supplier corrective action requests when necessary Maintains and continuously improves procedures and policies governing Supplier Quality Management Owns the electronic quality management system (EQMS), Veeva, including approval for document changes, training, change control, deviations, CAPA, and quality event workflows. Lead quality event management, including deviations, investigations, root cause analysis, CAPA, and effectiveness monitoring. Drives inspection readiness and continuous improvement initiatives Owns the change control process including review, approval, and verification of changes impact. Maintains and continuously improves the training program. Develops, monitors, and reports quality system metric and KPIs, identifying trends and driving initiatives. Provides quality system data and metrics for Management Review and support action planning.

Skills:

Demonstrated industry knowledge of cGMP Strong communications skills: a team player who collaborates on complex projects Experience participating and/or supporting regulatory inspections required

Qualifications:

BS degree in Biology, Biochemistry, Chemistry, or a relevant scientific discipline is required Certification as a Quality Auditor (ASQ or similar organization) preferred 10+ years of relevant cosmetic, biotech, and/or pharma industry experience, including Quality Assurance experience supporting cGMP areas

Additional Information Schedule:

Monday -

Friday Work Location:

Rochester, MN Work Remotely:

No Job Type:

Full-time The Benefits Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives. We provide a competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by

Rion:

Full Health, Dental and Vision Insurance for employees and their dependents. Choice between PPO or High Deductible Health Plan with Health Savings Account (HSA) Flexible Spending Accounts (FSA) 401K Retirement Savings Plan Life Insurance Programs Basic life and supplemental life insurance options for self, spouse, children Short and Long-Term Disability Insurance Discretionary Time-off, Paid Holidays, and Parental Leave programs Parking Benefits EEO Statement Rion is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. Recruitment & Staffing Agencies Rion does not accept agency resumes unless contacted directly by internal Rion Talent Acquisition. Please do not forward resumes to Rion employees, or any other company locations; Rion is not responsible for any fees related to unsolicited resumes. All resumes can be sent to careers@riontx.com Our Perks Health Insurance Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Supplemental Life Insurance Short and Long-Term Disability Insurance Paid Family Leave Paid Time Off Paid Holidays Parking Benefits Health Insurance Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Supplemental Life Insurance Short and Long-Term Disability Insurance Paid Family Leave Paid Time Off Paid Holidays Parking Benefits

EEO STATEMENT RION

is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. RION strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

RECRUITMENT & STAFFING AGENCIES RION

does not accept agency resumes unless contacted directly by internal RION Talent Acquisition. Please do not forward resumes to RION employees, or any other company locations; RION is not responsible for any fees related to unsolicited resumes.