How Will You Make an Impact?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

What will you do?

• Lead sustaining activities with current products to determine top issues in field and drive improvements to reduce product issues.

This includes review and investigate

a) customer complaints/feedback,

b) product quality trend and address product issues.

c) Feedback and support supplier quality and on product complaint investigation related to suppliers.

d) Drive on-going product improvement activities

e) Chair PQT monthly meeting.     

• Develop, implement and coordinate quality programs, including tracking, analyzing, reporting and problem solving.
• Work with cross-functional teams to ensure a successful and high quality product release.
• Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.
• Ensure that system and procedure are in compliance with ISO13485, ISO14971 and FDA 21 CFR Part 820 requirements
• Engaging in design reviews and new product qualification activities to ensure customer specified quality and reliability requirements are met.
• Manage quality escalation issues.
• Support cost reduction initiatives as participates in evaluation and qualification of material and process
• Evaluate product return and drive failure for investigation.
• Support plant-wide activities and special projects, as assigned.
• Drive product improvement activities to ensure customer satisfaction and ensure compliance to site quality management system.

How will you get here?

Education

• Degree in Engineering (Electronics or mechanical)

Experience

• Experience in quality function dealing with medical devices/IVD devices/Pharmaceutical
• Knowledge of process validation and sterilization would be an added advantage

Knowledge, Skills, Abilities

• Strong analytical skills to detect and resolve problems
• Strong communicator; hands on; ability to execute
• Take ownership and able to work independently
• Good knowledge of ISO13485, ISO14971 and 21CFR Part 820
• High energy level; positive attitude; works well under stress