Jobs for People with MS: National MS Society

Senior Manager, Quality Assurance

Manchester, Lancashire, United Kingdom

Hologic is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases and to aid in biomedical research. We also a lead in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women.

We are dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments.

There has never been a more exciting time to join us as our Senior Manager, Quality – Product Assurance.

Leading our dynamic quality team within molecular diagnostics team to further success, our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.

What To Expect

Leading Quality Inspections

• Ensure the proper level of inspections are conducted

• Sampling size is adequate for the risk level of the materials

• Supplier issues are communicated to appropriate groups

Product Release

• Ensure only conforming products are released into inventory

• Manage the at-risk program

NCEs/CAPAs and Escalating issues

• Ensure nonconforming materials are controlled and properly dispositioned

• Issues are escalated and investigated and adequately addressed or mitigated

• All related processes are aligned and seamless with the NCE/CAPA processes (i.e. PDV, rework, retest, etc.)

• Work with teams to ensure NCEs and CAPAs are timely

• Manage any escalated issues from complaints, NCEs, CAPAs, trends, Management Review, etc.

Reviewing and improving QMS processes

• Continually review and drive improvements of QMS processes within the scope of responsibility.

• Communicate regularly with global teams to ensure all risks and project updates are compliant

Strategic workforce planning

• Define and monitor department goals, budgets, projects and priorities

• Assess and develop skillsets required of all team members, monitoring development plans and group KPI’s

• Maintain a working knowledge of the Hologic products this position supports

• Work cross functionally with planning, manufacturing and other departments to minimize efficiency

• Promote awareness of regulatory requirements

• Accurately and effectively translates applicable requirements into workable systems and procedures

What We Expect

• B.S. in a scientific discipline with at least 8 years of relevant experience in quality, regulatory, or molecular diagnostics

• Proven people management expertise

• Experience with FDA and other regulatory agencies.

• Advanced knowledge of QSRs, ISO 13485, ISO 14971, MDSAP, and IVDR.

• Proficiency in risk management, sampling plans, team leadership, and budget development.

• Familiarity with EDMS and ERP systems, root cause analysis, and project management.

• Excellent communication skills (written, verbal, and presentation).

What’s in it for you?

• A dynamic work environment where your ideas lead to tangible impacts.

• Competitive salary and benefits package, including health insurance

• Opportunities for professional growth and development within a global company.

• A supportive, diverse, and inclusive culture focused on innovation and teamwork.

Join us at Hologic, where your expertise and passion can help redefine the future of healthcare. Apply now and become a part of our mission to make a world of difference!

This position is a Fixed Term Contract.

#LI-HE1