Engineer, QA/QC (Product Quality)

Engineer, QA/QC (Product Quality)

Thermo Fisher Scientific
3-6 years
Not Specified

Job Description


Job Description :
How Will You Make an Impact
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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 .
What will you do
Responsibilities:

  • Retrieve 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 escalated complaint(s) from various database into Trackwise System.

  • Initiate due diligence attempts to obtain missing information from complaint originator.

  • 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 Product QC inspection criteria and provide training to QC Technicians.

  • Identify and establish 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 return for FA(Failure Analysis) and ensures it returns for FA.

  • 10.Perform failure analysis on product failures and work with Engineering to resolve product faults.

  • Establish DMRI(Device Master Record Index).

  • Review change orders.

  • Review 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

  • 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.

  • Act as Operation QA Representative for NPI and project transfer.

  • Act as Compliance QA Representative for NPI and project transfer.

  • Act as Customer representative, attend to customer enquiries / feedback, assist in customer visit, coordinate and lead the team in customer audits.

  • Lead in quality initiatives program to address system inadequacies which may include quality programs, tracking, analyzing, reporting and problem solving to 23. achieve continual quality improvement objectives.

  • Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.

  • Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971 and FDA 21CFR Part 820 requirement.

  • Support plant-wide activities and special projects, as assigned.

How will you get here
Education

  • Degree in Engineering (Mechanical or Electronics) or Degree in Science (Biology, Chemistry, Bioengineering)

Experience

  • Experience in quality function dealing with medical devices/ IVD devices/ Pharmaceutical. with > 3 years of experience.

  • Knowledge of IVDR and IVD requirement would be an added advantage with > 3 years of experience.

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 ISO 9001, ISO13485, ISO14971 and 21CFR Part 820.

  • High energy level positive attitude works well under stress.

  • Knowledge in using Agile PLM, SAP, Trackwise and E1.

Job Details

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