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Senior QA Engineer

1 hour, 36 minutes ago
Singapore
Senior
QA Engineer
Quality Assurance and Testing
Apply Now
10x Genomics

10x Genomics

10x Genomics provides innovative genomics tools that enable researchers to explore single-cell and spatial biology, facilitating groundbreaking discoveries that enhance understanding of health and disease to improve human health outcomes.

Biotechnology
1K-5K
Founded 2012
$243M raised
View All Jobs 21

Description

  • Collaborate with R&D and Engineering to ensure products meet quality, manufacturability, and reliability requirements from pilot build through production.
  • Provide quality oversight and guidance to internal teams and contract manufacturers during new product introduction and production transfer.
  • Participate in build readiness reviews, risk assessments, and issue resolution to support a smooth transition from pilot to full production.
  • Partner with contract manufacturers and key suppliers to ensure product and process quality meet company requirements.
  • Assess, develop, and continuously improve supplier quality systems in alignment with ISO 9001 and ISO 13485 standards.
  • Conduct supplier audits, process reviews, and performance monitoring using quality metrics and KPIs.
  • Lead root cause analysis and corrective action implementation for supplier-related issues, including SCAR management.
  • Lead investigation and resolution of nonconformances, deviations, and manufacturing issues from internal production teams.
  • Support customer complaint investigations, including containment, root cause identification, and CAPA implementation.
  • Drive continuous improvement in instrument assembly processes, quality procedures, documentation, and control processes.

Requirements

  • Bachelor’s degree in Mechanical Engineering or an equivalent field.
  • Demonstrable experience in complex instrumentation or electro-mechanical system manufacturing within the Life Sciences or Medical Device industry.
  • Strong technical understanding of precision assemblies, motion systems (X-Y stage), instrument fixtures, and testing tools.
  • Proven experience working with contract manufacturers and managing supplier quality and performance, including participation in NPI cycles.
  • Experience in supplier development or supplier management/vendor quality system enhancement.
  • Understanding of ISO 9001 and/or ISO 13485 quality management system requirements.
  • Knowledge of CAPA, nonconformance, deviation, and SCAR management.
  • Strong problem-solving and analytical skills with a track record of driving quality and process improvements.
  • Excellent communication and collaboration skills with cross-functional partners.
  • Professional quality certification such as CQE, CQA, or Six Sigma Green/Black Belt is preferred.
  • Knowledge of software and firmware integration testing in complex instruments is preferred.
  • Proficiency with data analysis and quality tools such as 8D, FMEA, SPC, and Pareto is preferred.

Interested in this position?

Apply directly on the company website

Apply Now

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