Thermo Fisher Scientific · 3 days ago
Engineer III, QA
Rochester, NY
Full-time
Onsite
Mid, Senior Level
$76K/yr - $100K/yr
5+ years expThermo Fisher Scientific is a company dedicated to making the world healthier, cleaner, and safer. The Quality Engineer III role focuses on ensuring quality excellence and regulatory compliance across manufacturing operations, supporting the mission of delivering high-quality products that meet customer and regulatory requirements.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Interact with Technical Support, Customer Service, Sales Representatives, Product Managers, and/or customers by email, phone, and/ or in-person to ensure that information and samples necessary to investigate a customer complaint are received (and credit or replacement product is issued to a customer for confirmed complaints)
Interact with Customer Quality team in order to perform an impact assessment (severity, occurrence, and detection) for a complaint; evaluate and understand how complaint samples compare to established specifications; and review data to determine if a complaint is an isolated incident or a systemic issue
Lead customer complaint investigations working with cross-functional teams including Quality Assurance, Engineering, Manufacturing, and Research & Development in order to identify the root cause, corrections, and corrective and preventive actions
Submit work orders and interact with Quality Control in order to evaluate or understand how complaint samples compare to established specifications
Document the root cause, corrections, and corrective and preventive actions in the CAPA System (TrackWise); write a Corrective Action Response (CAR) that contains a summary of the investigation, corrections, and corrective and preventive actions; and utilize the Complaint Management System (SalesForce.com) to both document and communicate the CAR to the customer on behalf of the site
Ensure Management is informed in a timely manner of any significant customer complaints
Analyze complaint trends and facilitate an investigation, root cause analysis, and the identification of corrective actions for products and processes with a cross-functional teams
Influence site quality goals and objectives based on Customer complaints. Act as a subject matter expert when determining clarifications and compliance to written standards, providing additional information to the site to ensure consistent application of the Customer Complaint Management processes
Maintain and update the Customer Complaint Management process to ensure compliance with current regulations and standards
Manage and support the customer quality agreement process and questionnaire requests (which includes maintaining and updating the supplier qualification package)
Lead and manage the on-site or virtual customer audit process (which includes the assessment, scheduling, execution, and response activities)
Complies with required quality, safety, and operation/distribution quality system documents - such as our quality manual and policy, good documentation practices, plant safety commitments, general safety requirements, personal protective equipment program, and good manufacturing and distribution practices - as applicable
Performs other duties as needed
Qualification
Required
At least 5 years' experience in direct Quality Assurance
At least 1 year of demonstrated leadership experience (leading projects) is preferred
Bachelor's degree in related field, or consideration of an equivalent combination of education and experience
Working experience in a regulated (FDA Quality System Regulations (21 CFR Part 820)) and certified International Organization for Standardization (ISO) (13485:2016) Quality System
Strong desire to improve product quality and satisfy customer
Ability to multi-task and balance multiple priorities at the same time while focusing and carrying out tasks in a timely and accurate manner
Well organized and structured and detail-oriented
Ability to work effectively and build and maintain collaborative relationships with individuals and teams across functional boundaries at all levels of the organization
Proven ability to influence internal and external customers and lead changes
Ability to communicate effectively, both verbally and in writing, with internal and external customers
Ability lead and work on complex issues of moderate scope
Ability to act as an advisor/coach to other team members and provide quality guidance to the organization
Working knowledge of quality tools (DMAIC, Risk Management)
Ability to use all of the following PC applications: Microsoft Word, Excel, and PowerPoint
Preferred
Previous experience in a customer facing role is preferred
Science or Engineering Degree preferred
Lead Auditor Certification preferred
Experience interacting with external customers is preferred
Working knowledge of ERP Systems (SAP and/or E1), Complaint Management System (SalesForce.com), CAPA System (TrackWise), and Document Control System (MasterControl and/or Agile) is preferred
Benefits
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
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
EIN Presswire
2026-01-07
EIN Presswire
2026-01-05
Company data provided by crunchbase