Manager Quality Assurance, Validation

Danaher Corporation • Chaska, MN

1d • $130,000 - $160,000 • Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Quality Assurance Manager, Validations is located in Chaska, MN and reports to the Director of Quality Assurance. Our analyzers and reagents are medical laboratory devices used to calculate the concentration of certain substances within samples of serum, plasma, urine and/or other body fluids. Substances analyzed through these instruments include certain metabolites, electrolytes, proteins, and/or drugs. The Quality Assurance Manager partners with the manufacturing operations and development teams to ensure delivery of high quality, reliable and compliant products. This position will manage professional associates and operation support assigned to the Quality Assurance line support and validation team management, equipment program management, Design Change teams responsible for cost savings and supply continuity, including 7+ direct reports, instilling and sustaining a culture of Quality across the teams. This role also includes the following opportunity to: Develop objectives, measures progress against goals, and complete performance reviews for direct reports. Responsible for the performance and results of the teams. Adapt departmental plans and priorities to address resource and operational challenges, working cross functionally with other managers to align site objectives, as needed. Create an environment that attracts, develops, and retains high quality associates. Champion employee engagement, diversity, professional development and high levels of employee satisfaction. Use policies, procedures and business/department plan to guide decisions and problem solving.

Requirements

• Bachelor’s degree with 9+ years of experience or Master’s degree with 7+ years of experience. (Degree preferably in Chemistry, Biology, or similar scientific field)
• Previous management/supervisory or project management or leadership experience.
• Requires in-depth understanding of concepts, theories and principles within Quality Systems, Process Validation, Test method validation and Manufacturing Quality disciplines and basic knowledge of other disciplines.
• Experience with non-product software validation for manufacturing automation
• Manufacturing process validation experience - medical device or pharmacy industry highly preferred
• Experience with Quality System Regulation 21 CFR 820, Quality Management System ISO 13485:2016 and ISO 9001:2015

Nice To Haves

• Experience with equipment lifecycle management
• Lead Auditor Certification

Responsibilities

• Develop objectives, measures progress against goals, and complete performance reviews for direct reports.
• Responsible for the performance and results of the teams.
• Adapt departmental plans and priorities to address resource and operational challenges, working cross functionally with other managers to align site objectives, as needed.
• Create an environment that attracts, develops, and retains high quality associates.
• Champion employee engagement, diversity, professional development and high levels of employee satisfaction.
• Use policies, procedures and business/department plan to guide decisions and problem solving.

Benefits

• Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
• Check out our benefits at Danaher Benefits Info.
• We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager