Quality Specialist III

Quality Specialist IIIAs 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.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 9001:2015Serve as site SME for ISO 9001 requirements and interpretationImprove awareness of QMS requirements at the shop-floor levelOwn the internal audit program and develop and execute annual internal audit scheduleDrive systemic CAPA implementation and effectiveness verificationLead ISO 9001 certification and surveillance auditsCollaborate with cross-functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actionsFoster a culture of quality excellence throughout the organizationRequirements: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 fieldDemonstrated experience leading ISO 9001 QMS initiatives.Experience with quality management systems, CAPA processes, deviation management, and change controlDemonstrated expertise in root cause analysis, investigation techniques, and corrective action implementationProficiency in statistical analysis, data trending, and quality metrics reportingStrong technical writing skills for authoring SOPs, investigation reports, and other quality documentationExperience conducting and hosting internal/external auditsAdvanced problem-solving abilities and attention to detailExcellent verbal and written communication skillsStrong interpersonal skills with ability to collaborate across functions and levelsProficiency with quality systems software (Document Control Systems) and MS Office SuiteAbility to work independently and guide cross-functional teamsMay require up to 10% travel (locally)Physical ability to work in manufacturing environments with PPE requirements as neededKnowledge of risk assessment methodologies and continuous improvement toolsProject management experience preferredCompensation and BenefitsThe 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 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 discount Avery Healthcare Group Ltd.