Danaher Corporation · 2 days ago
Quality Engineer - Validation & Change Control
Muskegon, MI
Full-time
Onsite
Mid LevelDanaher Corporation is a global science and technology innovator, and they are seeking a Quality Engineer to be the subject matter expert for validation strategies at their Muskegon site. The role involves reviewing documentation, managing change control, and participating in audits to ensure compliance with industry standards.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Review and approve user requirement documentation (URS), Failure Mode Effect Analysis (FMEA) and equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) protocols and/or Plans and Reports
Assist and approve deviation investigations, corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation activities
Be the subject matter expert for Change Control on launched products, managing the local Change Management Board
Improve and develop QMS work instructions and cross train as a backup for other QA members
Participate in quality walks and internal audits to ensure compliance with industry standards
Qualification
Required
Bachelor's degree from an accredited University or College, preferably in a Science or Engineering discipline
Multiple years working experience in Quality Assurance/Quality Engineering
Experience in equipment qualifications, process validations, cleaning validations and computer software validations
Previous experience in root cause, corrective action, preventative action and process improvement
Understanding of ISO 9001, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) requirements
Ability to travel up to 10% a year
Must have a valid driver's license with an acceptable driving record
Ability to lift, move or carry equipment up to 10lb frequently, and up to 25lbs infrequently
Preferred
Life Science, Pharmaceutical, Medical Device or Biopharma manufacturing environments
Analytical and problem-solving skills
Strong communication skills (written and oral) with associates at all levels of the organization
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.
Founded in 1969
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
Investor's Business Daily
2025-12-05
2025-11-19
Company data provided by crunchbase