Sr QC Engineering Assistant

Location: Singapore, Singapore

Category: Quality & Regulatory

Employment Type: Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:
Singapore, Marsiling

How Will You Make an Impact?:
Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Sr QC Engineering Assistant, you will set up and maintain both incoming and outgoing quality inspection criteria to ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives for the QC team, as well as support the implementation of CAMSTAR Manufacturing Excellence System (MES) to manufacturing shopfloor. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

A Day in the Life:

• Maintain inspection criteria from the incoming inspection forms into SAP attributes (Master Inspection Characteristics and Inspection Plans).
• Reassign incoming inspection lot inspection plan and sampling size in SAP QM.
• Support QC engineer on incoming material setup for NPIs and transfer projects.
• Create and maintain inspection checklists / CAMSTAR user story for outgoing quality inspections.
• Support in safety compliance audits by Certification Bodies as well as external audits by regulatory agencies.
• Support QC Lead/ Engineer on tabulating quantitative data for review and monitoring.
• Work with cross-functional teams on resolution of technical issue impacting the QC team.
• Support QC inspections as needed.
• 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.

Education:

• Diploma in Engineering (Mechanical or Electronics) or in Science (Biology, Chemistry, Bio-engineering)

Experience:

• Required: Minimum of 2 years of work experience in QA or QC or related field
• Preferred: Experience in a cGMP environment

Knowledge, Skills, Abilities:

• 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.
• Strong organizational skills and attention to details.
• Able to work independently and be self-motivated.
• Good to have: Knowledge in using CMM and SmartScope Instrument.