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Discover Impactful Work:The Design Quality Assurance Staff Engineer will lead all aspects of the ‘end to end’ design control and new product development lifecycle as a quality core team lead for New Product Introductions (NPIs).A day in the Life:• Lead and support Design Control activities, providing guidance to Project Core Teams on User and Product requirements, Functional Specifications, Design Verification and Validation, Risk Management, Design Reviews, Design Changes, and Design Transfer.• Ensure activities are conducted in compliance with all applicable regulatory requirements, international standards, and internal procedures.• Actively identify and lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Design Quality organization.• Additional responsibilities as assigned.Education• BS degree in Engineering or in a Science field such as Chemistry, Microbiology, Biology, or Biochemistry.• Six sigma black belt preferred.• Instrument and Software experience preferred.Experience• 7+ years of Quality Assurance experience (Quality Engineering, Quality Assurance, Quality Control, Supplier Quality).• 5 + years of experience in New Product Introduction activities.• 5 + years in the Medical Device, In-Vitro Diagnostics, or other regulated industry.• Demonstrated understanding of product development lifecycles, design change and change control, product validation methodologies, design transfer, and manufacturing/ production process control methodologies.• Experience with applicable FDA, European and other relevant clinical/regulatory requirements, and international standards, including ISO 9001, ISO 13485, ISO 14971, EU IVDR/MDR, 21CFR 820 Quality System Regulation, etc.• Software and cybersecurity experience a plus.Knowledge, Skills, Abilities• Strong verbal and written communication skills and can communicate at multiple levels in the organization.• Ability to work efficiently within a team in a fast-paced changing environment.• Experience working in a broader enterprise/cross division business unit model preferred.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer a positive company culture that stands for integrity, intensity, involvement, and innovation!Compensation and BenefitsThe salary range estimated for this position based in Illinois is $93,800.00-$140,675.00.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: https://jobs.thermofisher.com/global/en/total-rewards
