Manager Quality Assurance, Validation

About the role

The Quality Assurance Manager, Validations is located in Chaska, MN and reports to the Director of Quality Assurance. This role is responsible for managing 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.

Responsibilities

• Partners with the manufacturing operations and development teams to ensure delivery of high quality, reliable and compliant products.
• Manages 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.
• Adapts departmental plans and priorities to address resource and operational challenges, working cross-functionally with other managers to align site objectives, as needed.
• Creates an environment that attracts, develops, and retains high-quality associates.
• Champions employee engagement, diversity, professional development, and high levels of employee satisfaction.
• Uses policies, procedures, and business/departments plans 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.

Qualifications

• Experience with equipment lifecycle management.
• Lead Auditor Certification.

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.

Pay

The annual salary range for this role is $130,000 to $160,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

Schedule

This job is also eligible for bonus/incentive pay.