Engineer III, QA

Work Schedule

Standard (Mon-Fri)

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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.

This position is located at the Rochester location, 75 Panorama Creek Dr., Rochester, NY 14625 within the Laboratory Plastics Essentials (LPE) Business Unit of the Laboratory Products Division (LPD).

As a Quality Engineer III, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer.

We are looking for a self‑driven, resourceful Quality Engineer with demonstrated experience driving and sustaining improvement to products while ensuring that those products manufactured meet internal, customer, and regulatory requirements. Under the direction of the Senior Manager, Quality Assurance, this position is responsible for executing the customer‑facing processes which include Complaint Management, Quality Agreements, and Audit Support as per the Quality System to ensure that the product or process quality requirements are fulfilled.

• 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 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 to identify the root cause, corrections, and corrective and preventive actions.
• Submit work orders and interact with Quality Control 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 (Track Wise); 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 () 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 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…