Engineer III, QA

Engineer III, QA 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.

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).

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

Standard (Mon‑Fri).

• 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 (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 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.

• At least 5 years' experience in direct Quality Assurance. At least 1 year of demonstrated leadership experience (leading projects) is preferred. Previous experience in a customer‑facing role is preferred.
• Bachelor's degree in related field, or consideration of an equivalent combination of education and experience. Science or Engineering Degree preferred.
• Working experience in a regulated (FDA Quality System Regulations…