Quality Engineer (US MNC, Lifescience, Start up)
1 day ago
Location: North SingaporeOffice Hours, Monday – FridayCompetitive Salary + AWS + Variable BonusMedical Benefits ProvidedAbout the role:Join a global l.....
- Location: North Singapore
- Office Hours, Monday – Friday
- Competitive Salary + AWS + Variable Bonus
- Medical Benefits Provided
About the role:
Join a global leader in the Life Sciences and Medical Technology industry. We are seeking a Quality Engineer to support quality assurance and continuous improvement initiatives across manufacturing, supply chain, and product development functions. This role offers the opportunity to work in a highly regulated environment and contribute to the quality and reliability of innovative scientific and healthcare products.
Job duties:
- Investigate product and system quality issues, perform root cause analysis, and recommend corrective actions.
- Support product testing activities by reviewing and evaluating test methods, protocols, and reports to ensure compliance with quality and regulatory requirements.
- Utilize statistical tools and data analysis techniques to drive quality improvements and support risk-based decision making.
- Collaborate with cross-functional teams to review engineering drawings, specifications, inspection plans, and manufacturing procedures.
- Establish critical quality characteristics and inspection requirements for components, sub-assemblies, and finished products.
- Drive continuous improvement initiatives using quality management tools and methodologies.
- Participate in product change control activities to ensure compliance with applicable quality and regulatory standards.
- Support risk management processes throughout the product lifecycle, including identifying, assessing, and mitigating quality risks.
- Monitor industry regulations, standards, and best practices relevant to medical devices and life science products.
- Contribute to quality system activities and support internal and external audits where required.
Job requirements:
- Bachelor's Degree in Engineering, Quality, Biomedical, Mechanical, Manufacturing, or a related scientific discipline.
- Minimum 3 years of experience in Quality Engineering within Medical Device, Life Sciences, Biotechnology, or regulated manufacturing environments.
- Knowledge of validation activities including Equipment Qualification (IQ/OQ/PQ) and process validation principles.
- Understanding of quality standards and regulations such as ISO 13485, ISO 14971, or FDA Quality System requirements will be advantageous.
- Experience with quality tools such as CAPA, FMEA, DOE, statistical sampling, and root cause analysis.
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Poh Tze Qi (Kayley) | R2197837
ScienTec Consulting Pte Ltd | 11C5781
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