Quality Engineer II – Manufacturing QA

About the role

Thermo Fisher Scientific is seeking a Quality Engineer II to support its manufacturing operations. The role ensures compliance with quality standards and regulatory requirements, driving continuous improvement and safeguarding product quality that impacts patient care.

Key responsibilities

• Retrieve and log customer complaints from multiple databases and update the complaint system.
• Review, process, and escalate complaints using the Trackwise system.
• Lead resolution of customer complaints and quality issues on the manufacturing floor.
• Define incoming and outgoing product QC inspection criteria and train QC technicians.
• Participate in product qualification activities, reviewing test protocols and reports.
• Issue Return Material Authorizations (RMA) and coordinate failure analysis with engineering.
• Establish and maintain Device Master Record Index (DMRI) documentation.
• Review change orders, deviations, and risk management documentation.
• Provide management with quality performance data and trend analysis.
• Support internal audits and act as the QA representative for New Product Introduction (NPI) and transfer projects.
• Represent the company in customer audits, visits, and feedback sessions.
• Lead quality improvement initiatives to address system gaps.

Required profile

• Experience ensuring compliance with quality standards and regulatory requirements in a manufacturing environment.
• Proven ability to lead investigations, root‑cause analysis, and corrective‑action implementation.
• Strong collaboration skills with cross‑functional teams, including engineering, operations, and customer support.
• Detail‑oriented mindset with the ability to translate customer feedback into actionable solutions.

Required skills

• Trackwise complaint management system.
• Failure analysis techniques and RMA processes.
• Device Master Record (DMR) and DMRI documentation.
• Quality Management System (QMS) audit participation.
• Risk management and change control procedures.