Senior QA Engineer

About The Role:

As a Senior QA Engineer, you will lead initiatives to assess, develop and enhance product and supplier quality. Utilizing your strong analytical, technical and collaborative skills, along with your experience in quality assurance for complex instruments, you will build robust quality strategies, foster strong supplier relationships and ensure the highest quality standards are met across products and supply chain.

What You'Ll Be Doing:

New Product Transfer

• Collaborate with R&D and Engineering to ensure product meets quality, manufacturability and reliability requirements from pilot build through production
• Provide quality oversight and guidance to internal teams and contract manufacturers throughout new product introduction and production transfer
• Participate in build readiness reviews, risk assessments, and issue resolution to ensure a seamless transition from pilot to full production

Supplier Quality Management

• Partner with contract manufacturers and key suppliers to ensure product and process quality meet requirements
• Assess, develop, and continuously improve supplier quality systems, driving alignment to company expectations and quality standards (ISO 9001/13485)
• 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
• Build strong collaborative relationships with suppliers to foster a culture of quality ownership and continuous improvement

Manage Quality Operations

• Lead investigation and resolution of nonconformances, deviations and manufacturing issues reported from internal production teams
• Partner with contract manufacturers and suppliers on failure analysis and corrective actions
• Support customer complaint investigations related to instruments, ensuring timely containment, root cause identification and CAPA implementation
• Drive ongoing quality improvements in instrument assembly processes both in-house and at suppliers

Continuous Improvement

• Support development and continuous enhancement of quality procedures, documentation and control processes
• Track and analyze key quality metrics to identify trends and drive preventive actions
• Support internal and external audits, qualification and regulatory compliance efforts
• Lead and participate in cross-functional quality improvement projects to strengthen product reliability and process robustness

Minimum Qualifications:

• Bachelor’s degree in Mechanical Engineering (or equivalent)
• 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

Preferred Skills And/Or Experience:

• Professional quality certification such as CQE, CQA or Six Sigma Green/Black Belt
• Knowledge of software and firmware integration testing in complex instruments 
• Proficiency with data analysis and quality tools (e.g. 8D, FMEA, SPC, Pareto)

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About 10x Genomics

At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.

We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.

Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference. 

Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.

10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.