Product Quality Engineer I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Discover Impactful Work:

• Product compliant handling, including retrieval of complaints from various database and update complaint log, review and process complaints in a uniform and timely manner. Review technical complaint threshold report and initiate raised complaint(s) from various databased into Trackwise System.
• 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.
• Identify and establish incoming/outgoing Product QC inspection criteria and provide training to QC Technicians.
• Participate in Product Qualification activities by reviewing test protocols and reports to ensure product quality meet the specified requirements.
• Issue RMA (Return Material Authorization) for units that requires to be returned for FA (Failure Analysis) and ensure it returns for FA. Perform failure analysis on product failures and work with Engineering to resolve product faults.
• Establish DMRI (Device Master Record Index).
• Review change orders, deviation and risk management for products.
• Provide COO (Country of Origin), COA (Certificate of Analysis), COC (Certificate of Conformance) upon request.
• Provide management with quality data and trends in product performance in meeting customer requirements.
• Participate in MRB (Material Review Board) meeting to review disposition of 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.
• Act as Operation/Compliance QA Representative for NPI (New Product Introduction) project and Transfer project.
• Participate in quality initiatives program to address system inadequacies which may include quality programs, tracking, analyzing, reporting and problem solving to achieve continual quality improvement objectives.
• 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.

Education / Experience

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

Knowledge, Skills, Abilities

• Knowledge of statistical controls and data analysis.
• Experience in Process validation activities in Quality function.
• High degree of computer literacy with xperience in the following will be most advantageous: SAP, Trackwise (QMS software), Salesforce (CRM software).
• Knowledge of MDSAP and/ or ISO13485 requirements.
• Good interpersonal skills, ability to interface effectively with many internal and external groups.
• Well organized and capable of self-management of projects.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.