Quality Engineer (US MNC, Lifescience, Start up)

• 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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ScienTec Consulting Pte Ltd | 11C5781