Thermo Fisher Scientific · 5 hours ago
Engineer II, QA
Marietta, OH
Full-time
Onsite
Mid Level
3+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking an Engineer II, QA to join their Quality Assurance team. This role is crucial for ensuring quality and compliance within the organization, supporting growth and innovation, and involves responsibilities such as facilitating audits, problem-solving quality issues, and mentoring on product-related investigations.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Knowledge of Regulatory and Quality system requirements (ISO 13485:2016)
Foster a collaborative relationship with Operations to promote a culture of ongoing education on the Quality Management System
Facilitate and participate in Customer / Internal audits
Apply problem-solving skills related to quality issues to ensure timely resolution with minimal impact
Embrace site PPI initiatives and adopt this methodology in day-to-day tasks
Take charge of plant-wide initiatives for addressing and preventing issues, with a key focus on handling customer returns and identifying root causes
Serve as a manufacturing liaison during new product development
Provide Quality mentorship for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs
Qualification
Required
Knowledge of Regulatory and Quality system requirements (ISO 13485:2016)
Ability to communicate effectively with multiple levels of leadership
Strong proficiency in technical writing and experience with various software applications, including Excel
Possess strong organizational and interpersonal skills to manage and prioritize multiple tasks
Ability to achieve deadlines in a fast-paced environment
Capability to work independently and collaboratively
Apply 21 CFR Part 820 and standard ISO 13485:2016 principles into critical daily decisions
High school diploma or equivalent experience required
Strong analytical and problem-solving skills
Effective communication skills across all organizational levels
Strong technical writing abilities and familiarity with software applications like MS Office or similar, SAP, Salesforce
Capable to prioritize in a fast-paced manufacturing organization
Embody the values of the quality culture
Mastery in conducting investigations and root cause analysis for complaints, non-conforming products, and CAPAs
This role requires the ability to work standing, walking, and occasionally lifting up to 25 pounds. Adherence to safety protocols is mandatory
Preferred
Bachelor's degree or equivalent experience preferred; applicable experience will be considered
Manufacturing environment desired
3 years' experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred
Benefits
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
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 (186)
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
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2025-12-25
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