Quality Engineer – Clinical Labeling

Work Schedule First Shift (Days)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob Description Quality Engineer – Clinical LabelingDivision / Site Specific InformationThe Bohemia, NY site is a key Thermo Fisher Scientific Global Label Services location, specializing in clinical trial labeling design, production, translation, and regulatory support for pharmaceutical and biotechnology companies.As a core Global Label Services site, Bohemia delivers fast, high-quality clinical trial labeling through integrated design, printing, inspection, translation, and regulatory support. The site enables accelerated global studies with advanced OCR inspection, temperature-specific labeling expertise, and dedicated clinical labeling project management.Discover Impactful WorkAs part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure quality excellence and regulatory compliance across clinical manufacturing operations—supporting our Mission to enable customers to make the world healthier, cleaner, and safer.You’ll collaborate across functions to uphold the highest quality standards while helping deliver clinical trial materials that support life-changing therapies worldwide.Day in the LifeEnsure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.)Maintain and improve Quality Management Systems (QMS) to ensure consistent quality performanceLead and support deviation investigations, root cause analysis, and CAPA implementationManage and participate in change control activities and risk assessments (FMEA)Support internal and external audits, including regulatory inspections and customer auditsPartner cross-functionally to resolve quality issues and drive continuous improvement initiativesSupport validation and qualification activities in alignment with ISPE principlesUtilize quality tools, metrics, and statistical analysis to monitor and improve processesCommunicate effectively with internal teams, external customers, and regulatory bodiesKeys to Success Education Advanced Degree with 3 years of experience ORBachelor’s Degree with 5 years of experiencePreferred fields: Engineering, Life Sciences, Chemistry, or related technical disciplineExperience Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech)Hands-on experience with:CAPA and deviation managementChange control processesRisk management and FMEADocument control systemsInternal and external auditingExperience supporting validation and qualification protocolsASQ certifications (CQE, CQA) strongly preferredKnowledge, Skills, Abilities Knowledge Strong understanding of cGMP, ISO standards, and global regulatory expectationsFamiliarity with ISPE validation and qualification conceptsKnowledge of statistical analysis and quality toolsSkills Advanced problem-solving and root cause analysisStrong project management and organizational skillsProficiency with quality management systems and MS OfficeExcellent verbal and written communication skillsAbilities Ability to work independently while collaborating across functionsHigh attention to detail with the ability to maintain a broader quality perspectiveStrong interpersonal skills to effectively partner with internal and external stakeholdersBenefits We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a comprehensive total rewards package. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects.Benefits include: Medical, Dental, & Vision benefits — effective Day 1Paid Time Off & Designated Paid HolidaysRetirement Savings PlanTuition ReimbursementRelocation assistance is not providedMust be legally authorized to work in the United States, now or in the future, without sponsorshipMust be able to pass a comprehensive background check, including drug screeningCompensation and Benefits The salary range estimated for this position based in New York is $83,300.00–$125,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits, please visit:

Thermo Fisher Scientific