Danaher Corporation · 8 hours ago
Quality Excellence Manager
Hauppauge, New York, United States
Full-time
Onsite
Mid, Senior Level
$120K/yr - $140K/yr
5+ years expCytiva, a Danaher operating company, is dedicated to advancing life sciences and biotechnology. As a Quality Excellence Manager, you will lead the Quality team, ensuring compliance and continuous improvement of the Quality Management System while collaborating with cross-functional leadership.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Serve as the site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals
Implement, maintain, and optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems support site operations and drive continuous improvement
Collaborate with site and global leadership to address process changes, advocate for site-specific needs, and drive customer-centric solutions during change management initiatives
Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological safety, and continuous improvement
Lead Quality Management Reviews, define and monitor KPIs, host audits, and represent the site in executive discussions and global best practice initiatives
Qualification
Required
Hold a Bachelor's degree in Science, preference in Chemistry or Engineering (or equivalent professional experience)
Have at least 5+ years in Quality Assurance or Quality/Process Engineering within FDA/EPA-regulated environments (Life Sciences, Biotechnology, Medical Device, Biopharma). Including 2+ years in validation and FMEA methodologies
Experience with contamination control, cleanroom operations, environmental monitoring, and microbiology preferred
Ability to lead, coach, and mentor teams through collaboration & influence; strong written and verbal communication across all organizational levels
Knowledge of ISO 9001/13485 standards, FDA regulations, cGMPs, CFR requirements, and quality systems (CAPA, complaints, change control, audits, risk management)
Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data-driven decision-making
Capacity to manage budgets, evaluate opportunity costs, and drive innovative problem-solving while maintaining exceptional organizational and time management skills
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
Prior leadership experience preferred
Experience with contamination control, cleanroom operations, environmental monitoring, and microbiology preferred
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Danaher Corporation
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
10001+ employees
H1B Sponsorship
Danaher Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown1979-01-05IPO
Leadership Team
Rainer Blair
President & CEO
Thomas Joyce
President & CEO
Recent News
Mobihealthnews
2026-01-16
2026-01-14
Company data provided by crunchbase