Quality Engineering Manager

Danaher Corporation•Pensacola, FL

2d•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 Cytiva, 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. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva, you will be able to continuously improve yourself and us – working on challenges that truly matter with people who care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System, which makes everything possible. 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. This position reports to the Senior Manager, Site Quality and leads the Quality Engineering team located in Pensacola, Florida. This is an on-site role. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

Requirements

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 & influence; strong written and verbal communication across all organizational levels.
Demonstrated expertise in investigations, CAPA, risk management, and change control.
Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data-driven decision-making and embracing AI.
Motivated, eager and excited to make a difference.

Nice To Haves

Previous Experience In Contamination control, sterilization, sanitation, or E-beam processes, including ISO 14644 cleanroom operations.
Enterprise systems such as SAP, Oracle, Veeva, or Magic, supporting laboratory or quality operations.

Responsibilities

Serves as the accountable owner for assigned quality events, CAPAs, and PSPs by owning decision‑making, risk assessment, coordination, escalation, and closure, while appropriately delegating execution tasks to responsible functions without relinquishing overall accountability.
Lead and manage Complaint Defect Tracking and Resolution (CDT&R) for products. Tasks include analyzing trends, tracking major issues and related corrective actions, triaging, coordinating and supporting investigations, writing and reviewing technical reports for customer, and interfacing with customers in various forms of communications.
Provide guidance to other cross-functional departments on Containment Actions, Root Cause Analysis, Investigation Activities, and Corrective Action Plans for internal non-conformances.
Review and approve Investigations and CAPAs owned by other departments
Apply DBS problem‑solving methodologies—including 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 in a regulated manufacturing environment.
Build a high-performing quality Engineering department, fostering a safe, empowering environment that encourages skill development, psychological safety, and continuous improvement.
Provide quality engineering leadership with 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.