Quality Engineering Manager

As the Quality Engineering Manager you will collaborate closely with cross‑functional leadership and associates to ensure compliant execution, monitoring, and continuous improvement. You will also provide support for new product introduction, process improvements and defect reductions.

• Serve as the accountable owner for assigned quality events, CAPAs, and PSPs, owning decision‑making, risk assessment, coordination, escalation, and closure while delegating execution tasks appropriately.
• Lead and manage Complaint Defect Tracking and Resolution (CDT R) for products, including trend analysis, major issue tracking, corrective action coordination, investigation support, technical report writing, and customer communication.
• Provide guidance on Containment Actions, Root Cause Analysis, Investigation Activities, and Corrective Action Plans, review and approve investigations and CAPAs owned by other departments.
• Apply problem‑solving methodologies such as root cause analysis, standard work, daily management, Six Sigma, and Lean principles to resolve quality challenges and prevent recurrence.
• Leverage statistical analysis and data visualization in Microsoft Excel to guide quality engineering decisions, support investigations, and drive continuous improvement.
• Develop and lead a high‑performing quality engineering department, fostering a safe and empowering environment that encourages skill development and psychological safety.
• Provide leadership expertise in ISO 13485 compliance, statistical sampling strategies, gage R R, validation (IQ/OQ/PQ), cleanroom environments, and DOE to support risk‑based, data‑driven decision‑making.

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• 5+ years of experience in Quality Engineering, Quality Assurance, or related quality roles within a regulated industry.
• 2+ years of people leadership or demonstrated experience leading cross‑functional teams.
• Strong working knowledge of ISO 9001 and/or ISO 13485, GMP principles, and QMS requirements.
• Ability to lead, coach, and mentor teams through collaboration and influence; strong written and verbal communication across all organizational levels.
• Demonstrated expertise in investigations, CAPA, risk management, and change control.
• Analytical and process‑optimization skills, including statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data‑driven decision‑making.

• Ability to travel 10% of the time to other Cytiva manufacturing locations in the US and worldwide as required.
• Ability to access gauges and equipment 5‑6 feet off the ground, lift and move 20‑35 lb. parcels.
• Preferred:
  Previous experience in contamination control, sterilization, sanitation, or E‑beam processes, including ISO 14644 cleanroom operations.
• Preferred:
  Enterprise systems such as SAP, Oracle, Veeva, or Magic, supporting laboratory or quality operations.

• Comprehensive benefit programs including medical, dental, vision insurance and paid time off.

• Eligibility for bonus/incentive pay.

• 401(k) plan to eligible employees.

• Broad array of competitive benefit programs that add value to life beyond the job.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
U.S. EEO posters are available at EEOC website.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact or