company10x Genomics logo

Senior Quality Assurance Engineer

10x GenomicsSingapore Office
On-site Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Unlock Your Potential

Generate Job-Optimized Resume

One Click And Our AI Optimizes Your Resume to Match The Job Description.

Is Your Resume Optimized For This Role?

Find Out If You're Highlighting The Right Skills And Fix What's Missing

Experience Level

Senior

Qualifications

Qualifications: Proven experience in quality assurance for complex instruments, ideally within a medical device or technology environment. Strong knowledge of quality management systems and regulatory standards including ISO 9001 and ISO 13485. Exceptional analytical and problem-solving abilities, with a keen eye for detail. Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and suppliers. Ability to lead and influence others in a fast-paced environment while managing multiple priorities.

About the job

About the Role:

As a Senior Quality Assurance Engineer at 10xgenomics, you will spearhead efforts to evaluate, develop, and improve both product and supplier quality. Your strong analytical, technical, and collaborative skills, complemented by your extensive experience in quality assurance for complex instruments, will enable you to establish robust quality strategies, cultivate solid supplier relationships, and guarantee that the highest quality standards are consistently met across products and the supply chain.

What You'll Be Doing:

New Product Transfer

  • Work closely with R&D and Engineering teams to ensure products satisfy quality, manufacturability, and reliability standards from pilot builds through to production.
  • Provide quality oversight and guidance to internal teams and contract manufacturers throughout the new product introduction and production transfer phases.
  • Engage in build readiness reviews, risk assessments, and issue resolution to facilitate a smooth transition from pilot production to full-scale manufacturing.

Supplier Quality Management

  • Collaborate with contract manufacturers and key suppliers to ensure that product and process quality aligns with company requirements.
  • Evaluate, develop, and continuously enhance supplier quality systems, striving for alignment with company expectations and quality standards (ISO 9001/13485).
  • Execute supplier audits, process reviews, and performance monitoring utilizing quality metrics and KPIs.
  • Lead root cause analysis and corrective action implementation for supplier-related issues, including SCAR management.
  • Forge strong collaborative relationships with suppliers to promote a culture of quality ownership and continuous improvement.

Manage Quality Operations

  • Oversee the investigation and resolution of nonconformances, deviations, and manufacturing issues reported by internal production teams.
  • Collaborate with contract manufacturers and suppliers regarding failure analysis and corrective actions.
  • Support customer complaint investigations related to instruments, ensuring prompt containment, root cause identification, and CAPA implementation.
  • Drive ongoing quality improvements in instrument assembly processes, both in-house and at supplier locations.

Continuous Improvement

  • Assist in the development and continuous enhancement of quality procedures, documentation, and control processes.
  • Monitor and analyze key quality metrics to identify trends and implement preventive actions.
  • Facilitate internal and external audits, qualification, and regulatory compliance activities.

About 10x Genomics

10xgenomics is a leader in innovative genomic technologies, dedicated to advancing human health by providing cutting-edge solutions that enhance scientific discovery. Our commitment to quality and excellence drives our mission to empower researchers and clinicians worldwide.

Similar jobs

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.