We are currently looking to add a Sr. Quality Systems Specialist to our team!
We hold every member of our team to a high standard of excellence – because everyone on our team makes an impact on our success and contributes to our ability to thrive in the rapidly changing environment. We are looking for a motivated person who is eager to learn and grow as a member of our team. In the Sr. Quality Systems Specialist role, you will have authority over and responsibility for maintaining and improving the quality management system at Microbiologics.
What can I expect in this role?
- Ensure that the quality system requirements are effectively established, implemented, and maintained in accordance with 21CFR820, ISO 13485, ISO 17025, ISO 17034, CE mark conformity, and other regulations and standards as directed by Director of Corporate Quality.
- Maintain and improve quality management system processes and procedures.
- Provide SME support and mentor others on QMS related issues.
- Apply effective problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Oversee and manage internal audit program, performing audits, training new auditors.
- Manage and host customer audits, regulatory audits, and audit responses.
- Assist in/perform CAPA investigations, root cause analysis, develop corrective actions, and verify effectiveness.
- Review process and equipment validation protocols/reports.
- Perform document control functions, including review and processing of change orders.
- Assist in supplier qualification and serve on the Material Review Board.
- Conduct supplier assessments and supplier audits.
- Backup to the Quality Systems Manager.
- Conduct annual cGMP/GDP training.
Who is Microbiologics?
Microbiologics is one of the fastest growing international biotechnology companies in the nation. We are the world’s leading experts and go-to collaborators in biological products and services, focused on protecting the health and safety of people around the world. For over 50 years, we have been partnering with healthcare and life science laboratories, manufacturers, and suppliers across the globe to co-create and provide biological control materials, assay services and consulting for microbiology, molecular diagnostics, and virology. Headquartered in Saint Cloud, Minnesota, we have additional facilities in California, Kentucky, and Michigan.
Our award-winning culture is friendly, collaborative, and supportive, providing endless opportunities for individuals to learn and grow, both personally and professionally. At Microbiologics, we believe that "great vision without great people is irrelevant." That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world.
What can we offer you?
Glad you asked!
We have a comprehensive benefits package that includes your standard benefits such as health and dental insurance, health savings account (company funded), life insurance, short and long-term disability, and a 401k program with a generous match to name a few. In addition, we are proud to support our team and their families by offering daycare assistance, tuition reimbursement, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and growth.
What makes you a good fit?
Our goal is finding the right individual for our team – we firmly believe that the right person is someone to invest in and invite to join our family.
Here is what we are looking for:
- Bachelor's degree required, preferably in a science/technical field.
- Minimum 5 years (10+ years preferred) of in-depth experience with hands-on Medical Device quality systems, including ISO 13485, 21CFR820, 21CFR11, ISO 14971, and EU IVDR.
- ISO 17025 and ISO 17034 experience preferred.
- Continuous improvement/lean manufacturing experience.
- ASQ CQA or equivalent auditing experience, both internal and supplier.
- Experience with process validations, equipment qualifications, IQ/OQ/PQ.
- Demonstrated ability to work effectively in a cross functional team.
- The ability to pass a background check and drug screening.
- Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required upon hire.