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Product Quality Engineer II
3 months ago
Process complain 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.
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.
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.
Participate in MRB (Material Review Board) meeting to review disposition of raw material, handle RMA (Return Material Authorization) and other quality related requests.
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
Degree in Engineering (Mechanical or Electronics)
Knowledge, Skills, Abilities
Knowledge of statistical controls and data analysis.
Experience in Process validation activities as Quality function.
Knowledge of the following system will be most helpful: ERP systems: SAP, QMS software: Trackwise, CRM software: SalesForce.
Knowledge of MDSAP and/ or ISO13485 requirements.
Ability to communicate and interact optimally with internal and external parties.
Well organized and capable of self-management of projects.
Experience : > 3 year in similar role
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
