About the role
Engineer II, Quality at Thermo Fisher Scientific in Singapore. Ensure compliance with quality standards and regulatory requirements in manufacturing. Drive continuous improvement, lead investigations, and implement corrective actions. Oversee non-conformance material process and review part qualification packages.
Life SciencesOnsite
Key Responsibilities
- Ensure compliance with quality standards and regulatory requirements
- Collaborate with cross-functional teams for continuous improvement
- Lead investigations and implement corrective actions
- Oversee non-conformance material (NCM) process
- Review and approve Part Qualification Packages
- Support external regulatory inspections
Requirements
- Bachelor's Degree in Life Sciences, Engineering, Chemistry or related field
- 2 years of quality assurance experience in GMP/ISO regulated environments
- Strong knowledge of quality systems, cGMP, ISO 13485, 21 CFR Part 820
- Expertise in risk management, root cause analysis, CAPA, change control
- Experience conducting internal audits
- Ability to work independently and in team environments