Engineer III, QA

Work Schedule

First Shift (Days)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

Job Title

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Job Description

Are you an ambitious engineer ready to make a significant impact? At Thermo Fisher Scientific Inc., we offer an outstanding opportunity to join a team that is dedicated to making the world healthier, cleaner, and safer. As part of our engineering team, you will collaborate with diverse teams to implement proven solutions and drive flawless execution in all aspects of our projects. This is your chance to be part of a dynamic and innovative environment!

Key Responsibilities

• Coordinate Tijuana plant activities related to customer complaints.
• Manage customer-complaint related CAPA (Corrective Action and Preventive Action) at the Tijuana plant.
• Identify root causes of problems and define necessary actions to ensure corrective and preventive actions are accurately implemented and detailed.
• Verify the efficiency of CAPAs.
• Participate in process and product improvement plans.
• Actively contribute to cost reduction and PPI (Practical Process Improvement) programs.
• Support Quality Assurance & Quality Manager during ISO 9001 and ISO 13485 certification processes.
• Initiate and close internal non-conformances (NCMs).
• Lead CAPA investigations, internal audits, and internal/external meetings.
• Supervise a group of Quality inspectors.
• Conduct trend analysis.
• Perform other duties as required.

Requirements

• Bachelor's degree or equivalent experience in Engineering or a related field.
• Proven experience in quality assurance or a similar role.
• Strong understanding of CAPA processes and ISO standards.
• Outstanding problem-solving and analytical skills.
• Ability to strictly adhere to deadlines and manage multiple tasks.