Quality Engineer - Clinical Labeling

Thermo Fisher Scientific•Town of Islip, NY

About The Position

Quality Engineer - Clinical Labeling Division / Site Specific Information The 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 Work As 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 Life 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 Keys to Success

Requirements

Advanced Degree with 3+ years of experience OR
Bachelor’s Degree with 5+ years of experience
Preferred fields: Engineering, Life Sciences, Chemistry, or related technical discipline
Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech)
Hands-on experience with:
CAPA and deviation management
Change control processes
Risk management and FMEA
Document control systems
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
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

Nice To Haves

ASQ certifications (CQE, CQA) strongly preferred

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

Benefits

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.
Medical, Dental, & Vision benefits – effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
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 programs
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