QA Senior Engineer

Thermo Fisher Scientific

Singapore
Permanent
Full-time

25 days ago

Job DescriptionWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.Discover Impactful Work:

Review and approves Part Qualification Packages (first article report, engineering drawing, RoHS declaration, etc) and Supplier Change Request package for any change request initiated by supplier.
Responsible to oversees non-conformance material (NCM) process to ensure the NCM Trackwise Problem Report (PR) is closed on timely manner.
Work with multi-functional teams to ensure timely disposition, risk impact assessment and investigation of NCM PR. Work with Warehouse, Engineering and Manufacturing to perform part screening to support manufacturing when urgent needs of the parts for manufacturing use.
Work with NCM PR users to reduce number of NCM PRs raised and reducing of NCM PRs extension.
Responsible to publish daily NCM Trackwise PR status to ensure no past due PR to meet the global metrics.
Lead and participates the Material Review Board meetings to review non-conformance material for its disposition on daily basis.
Work with Supplier Quality to perform SCAR effectiveness check to ensure the corrective/preventive actions is effectively implemented by suppliers.
Implement and maintain NCM Track and Trend program to provide data analyst and share with partners for parts performance trending.
Work with Engineering, Sourcing and Supplier Quality Team to review, assess and identify any unclear specifications in part drawings for part acceptance activities.
Participate and support external audits such as customer, ISO and regulatory audits.
Trained and be the site Trackwise Super User to support any trackwise process queries from all Singapore Manufacturing sites.
Participate Supplier Performance activities that driven by Supplier Quality or Procurement, if any.
Drive process improvement activities through PPI (Practical Process Improvement) to ensure compliance and improve customer satisfaction.
Ensure that systems and procedures are in compliance with ISO13485, MDSAP, FDA 21CFR Part 820, IVDR, ISO9001, ISO14001 and ISO45001 requirement.

Education / Experience

Bachelor Degree in Mechanical or Electrical/Electronic Engineering or equivalent.

5 years of experience in quality function dealing with medical devices / IVD devices / Pharmaceutical (experience in cGMP / ISO13485 environment) preferred.Knowledge, Skills, Abilities

Able to present and communicate concisely at all levels.
Independent with commitment to meet deadlines.
Firm in carrying out work without compromising on SOP/ Specification and standards.
Good knowledge of ISO/Regulatory Standard: FDA 21CFR Part 820, IS013485, MDSAP, ISO9001.
Strong analytical skills to detect and resolve problems.

BenefitsWe 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 . 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.Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific

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