Thermo Fisher Scientific · 18 hours ago
Quality Assurance Manager - Millersburg, PA
Thermo Fisher Scientific is a global leader in providing solutions for some of the world’s toughest challenges. The QA Manager leads day-to-day quality operations, ensuring compliance with industry standards and customer requirements while driving continuous improvement across products and services.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Lead a team of QA specialists responsible release of manufacturing lots, document control processes, external and internal audits, deviation management and CAPA, and change control processes
Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions
Establish & maintain quality metrics to measure progress against goals
Execute & maintain risk assessments related to QA processes
Provide effective oversight of the execution of the site Quality Improvement Plan, Risk Management activities and of all design related activities during the product/system lifecycles
Interface directly with customers and internal groups
Effectively use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives
Coach and support team members through their technical and professional development
Communicate effectively across all site functions and quality teams, as well as with network and divisional leadership, to drive alignment and a strong site quality culture
Prepare for and actively support external audits (customer & regulatory) ensuring corrective/preventative actions are put in place to address identified non-conformances
Provide leadership to the quality function necessary to ensure that strategic and annual quality planning is integrated into strategic and operating plans with broad-based organizational involvement
Qualification
Required
Bachelor's degree (or higher) in an engineering, science, operations or related field
Minimum of 8 years of professional experience in an Engineering, Quality or Operations related role
Minimum of 3 year experience as people manager
Experience related to continuous improvement/lean processes
Ability to manage & implement changes with minimal supervision, onsite and remotely at global locations
Must be able to influence & negotiate with people & resolve issues
Ability to make rational, objective and appropriate decisions relating to company & department requirements
Ability to identify customer needs and issues
Develop realistic solutions to meet customer needs and solve problems
Communicate recommendation and decisions across the organization
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes
Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements
Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions
Experience working with ISO 13485
Understanding of plastics- materials, properties, manufacturing processes, and product assembly
Strong communication and writing skills
Excellent communication and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point
Working experience with cGMP requirements (21 CFR 820)
Ability to analyze and process data and draw the appropriate conclusions
Experience prioritizing conflicting demands
Excellent interpersonal, organizational, and influencing skills
Ability to analyze and process data, and draw the appropriate conclusions
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
H1B Sponsorship
Thermo Fisher Scientific 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 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Recent News
CB Insights
2026-01-23
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