Thermo Fisher Scientific · 11 hours ago
Quality Engineer - Clinical Labeling
Bohemia, NY
Full-time
Onsite
Mid, Senior Level
$83K/yr - $125K/yr
3+ years expThermo Fisher Scientific is a leading company specializing in clinical trial labeling design and production. In this role, you will ensure quality excellence and regulatory compliance across clinical manufacturing operations, collaborating across functions to uphold the highest quality standards while delivering clinical trial materials that support life-changing therapies worldwide.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Ensure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.)
Maintain and improve Quality Management Systems (QMS) to ensure consistent quality performance
Lead and support deviation investigations, root cause analysis, and CAPA implementation
Manage and participate in change control activities and risk assessments (FMEA)
Support internal and external audits, including regulatory inspections and customer audits
Partner cross-functionally to resolve quality issues and drive continuous improvement initiatives
Support validation and qualification activities in alignment with ISPE principles
Utilize quality tools, metrics, and statistical analysis to monitor and improve processes
Communicate effectively with internal teams, external customers, and regulatory bodies
Qualification
Required
Advanced Degree with 3+ years of experience OR Bachelor's Degree with 5+ years of experience
Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech)
Hands-on experience with CAPA and deviation management
Hands-on experience with change control processes
Hands-on experience with risk management and FMEA
Hands-on experience with document control systems
Hands-on experience with internal and external auditing
Experience supporting validation and qualification protocols
Strong understanding of cGMP, ISO standards, and global regulatory expectations
Familiarity with ISPE validation and qualification concepts
Knowledge of statistical analysis and quality tools
Advanced problem-solving and root cause analysis skills
Strong project management and organizational skills
Proficiency with quality management systems and MS Office
Excellent verbal and written communication skills
Ability to work independently while collaborating across functions
High attention to detail with the ability to maintain a broader quality perspective
Strong interpersonal skills to effectively partner with internal and external stakeholders
Must be legally authorized to work in the United States, now or in the future, without sponsorship
Must be able to pass a comprehensive background check, including drug screening
Preferred
Preferred fields: Engineering, Life Sciences, Chemistry, or related technical discipline
ASQ certifications (CQE, CQA) strongly preferred
Benefits
Medical, Dental, & Vision benefits – effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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
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
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
Company data provided by crunchbase