Thermo Fisher Scientific · 1 day ago
Quality Specialist II
Detroit, MI
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a global leader in serving science, focused on impactful work and innovative thinking. The Quality Specialist II will support product release activities and ensure compliance with the Quality Management System (QMS) at the Detroit, Michigan campus, specifically within the Biologicals and Chemicals Division.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Complete Quality record reviews including, but not limited to, batch history records, equipment and calibration documentation, QC records, and shipping records
Support timely delivery of products to customers through lot release (raw materials and manufactured product) and preparation of certificates of analysis
Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, supplier questionnaires
Maintain Quality records according to Thermo Fisher Scientific policies and procedures
Maintain the site’s Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable
Support the execution of the site's training program
Support internal and external audits and ensure compliance with site and industry standards
Assist in completion of various QMS requirements, including but not limited to quality management reviews, change management including document change control, and customer notifications
Other projects will be assigned as various business needs arise
Qualification
Required
A Bachelor's Degree is required
Minimum of 2 years' experience in a Quality Assurance function in an ISO 13485 environment
Strong critical thinking skills, with a close attention to detail and history of good judgment
Proven ability to prioritize work according to urgency and impact, with good time management skills
Driven and resourceful, with minimal to moderate direction required
Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfortable with learning and using new software programs
Strong technical writing skills
Proven ability to work in a team and matrixed environment
Preferred
A science major preferred
Familiarity with the life sciences industry is desired
Record review and/or auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred but not required
Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages
Benefits
Competitive remuneration
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 (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
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
EIN Presswire
2026-01-07
EIN Presswire
2026-01-05
Company data provided by crunchbase