Quality Engineering Manager

Posted 3 Hours Ago
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Pensacola, FL, USA
In-Office
Senior level
Healthtech • Other • Software • Biotech
The Role
As Quality Engineering Manager, you will lead compliance, defect resolutions, and improvement initiatives in a regulated environment, fostering team development and applying quality engineering methodologies.
Summary Generated by Built In

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.

What you will do:

  • 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.
  • Team Development & Performance: 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.

Who you are:

  • 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.
  • Analytical & Process Optimization: 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.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

  • 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.
It Would Be a Plus If You Also Possess 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.

Cytiva, 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.

This job is also eligible for bonus/incentive pay. 

 

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. 

 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here.

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:1-202-419-7762 or [email protected].

Skills Required

  • Bachelor's degree in Engineering, Science, or a related technical discipline
  • 5+ years of experience in Quality Engineering, Quality Assurance, or related quality roles
  • 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
  • Demonstrated expertise in investigations, CAPA, risk management, and change control
  • Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis

Beckman Coulter Diagnostics Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.

  • Healthcare Strength Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
  • Leave & Time Off Breadth Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
  • Parental & Family Support Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.

Beckman Coulter Diagnostics Insights

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The Company
HQ: Brea, CA
10,526 Employees
Year Founded: 1935

What We Do

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

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