Quality Specialist III

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION

Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will provide strategic oversight of QMS processes across our two of our CT manufacturing facilities (Meriden and Stafford Springs), lead internal and external audit programs, drive systemic corrective actions (CAPA), and partner cross-functionally with Operations, Engineering, Supply Chain, and Leadership to embed quality into production processes. This role serves as a subject matter expert (SME) in

ISO 9001

2015 and manufacturing quality controls, ensuring compliance while driving operational excellence. How you will make an impact: Lead implementation and maintenance of the QMS aligned with

ISO 9001

2015 Serve as site SME for

ISO 9001

requirements and interpretation Improve awareness of QMS requirements at the shop- floor level Own the internal audit program and develop and execute annual internal audit schedule Drive systemic CAPA implementation and effectiveness verification Lead

ISO 9001

certification and surveillance audits Collaborate with cross- functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actions Foster a culture of quality excellence throughout the organization

REQUIREMENTS

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance/quality control within regulated industries (pharmaceutical, medical device, biotech preferred)

Preferred Fields of Study:

Life Sciences, Engineering, Chemistry, Biology or related technical field

• Demonstrated experience leading

ISO 9001 QMS

initiatives.

• Experience with quality management systems, CAPA processes, deviation management, and change control
• Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation
• Proficiency in statistical analysis, data trending, and quality metrics reporting
• Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation
• Experience conducting and hosting internal/external audits
• Advanced problem-solving abilities and attention to detail
• Excellent verbal and written communication skills
• Strong interpersonal skills with ability to collaborate across functions and levels
• Proficiency with quality systems software (Document Control Systems) and MS Office Suite
• Ability to work independently and guide cross-functional teams
• May require up to 10% travel (locally)
• Physical ability to work in manufacturing environments with PPE requirements as needed
• Knowledge of risk assessment methodologies and continuous improvement tools
• Project management experience preferred Compensation and Benefits The salary range estimated for this position based in Connecticut is $83,300.

00-$115,000.00. 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 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 For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.