Senior Engineering Assistant, QC

Job Description

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

• Maintain Inspection criteria from the incoming inspection forms into SAP attributes (Master inspection characteristics and inspection plans).
• Reassign incoming inspection lot/s inspection plan and sampling size in SAP QM.
• Support QC engineer on NPI and product transfer on incoming material setup.
• Support QC Lead/ Engineer on tabulate quantitative data for review and monitoring.
• Work with multi-functional team on resolution of technical issue arise by the QC team.
• Compile and verify quality inspection records, approved COC/ COA to facilitate traceability for demonstration of product compliance for analysis by QC Supervisor.
• 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.
• Support company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA reulations.
• Ensure that systems and procedures are in compliance with ISO 9001, ISO 13485, ISO 14971, ISO 45001 and FDA 21CFR Part 820.
• Support plant-wide activities and special projects, as assigned.

• Diploma in Engineering (Mechanical or Electronics) or in Science (Biology, Chemistry, Bio-engineering with min 2 year working experience, preferably in manufacturing environment.

• Good understanding and experience in using SAP QM.
• Experience in performing incoming and outgoing inspections.
• High degree of digital literacy, experience in the following will be most advantageous : TrackWise, Microsoft Office applications.
• Proactive and assertive attitude; willingness to be highly visible and accountable.
• Good to have: Knowledge in using CMM and SmartScope Instrument.