Product Quality Engineer II

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Discover Impactful Work:

• Compliant handling, including retrieval of complaints from various database and update complaint log, review and process complaints in a uniform and timely manner.
• Lead in the resolution of customer complaint and quality issues on manufacturing floor to provide voice of customers to operations and translate customer's feedback into innovative solutions.
• Perform failure analysis on product failures and work with Engineering to resolve product faults. Establish DMRI (Device Master Record Index).
• Review change orders, deviation, risk management for products or disposition of raw materials.
• Act as supplier quality engineer role for inter-company purchased raw material.
• Participate in internal audits to ensure the effective implementation of Quality Management System and ensure procedures are in compliance with ISO13485, MDSAP, FDA 21CFR Part 820, IVDR, ISO9001, ISO14001 and ISO45001 requirement.
• Supports company goals and objectives, policies, and procedures in compliance with quality systems, cGMP and FDA regulations and support plant-wide activities and special projects, as assigned.

• Degree in Engineering (Mechanical or Electronics) or Science (Biology, Chemistry, Bio-engineering with min 2 years working experience, preferably in manufacturing environment.
• min 1 year experience in Quality function , dealing with medical devices / IVD devices / Pharmaceutical preferred.

• Knowledge of statistical controls and data analysis with experience in Process validation activities in Quality function.
• High degree of computer literacy with experience in the following will be most advantageous: SAP, Trackwise (QMS software), Salesforce (CRM software).
• Knowledge of MDSAP and/ or ISO13485 requirements and Mass Spectrometry will be most advantageous.
• Well organized and good communication skills, to effectively manage internal and external partners.