Senior Quality Engineer
Location: Pleasanton, CA
10x Genomics is building tools for scientific discovery that reveal and address the true complexities of biology and disease. Through a combination of novel microfluidics, chemistry and bioinformatics, our award-winning Chromium™ System is enabling researchers around the world to more fully understand the fundamentals of biology at unprecedented resolution and scale. Learn more at 10xGenomics.com.
Fueled by equal parts scientific vision and determined passion, we are delivering unprecedented innovation to short-read sequencing technologies and transforming how genomic information is accessed. You will feel the 10x difference the moment you enter our offices and labs. There’s a dynamic energy here, and we’re looking for the best of the best to be a part of it. We are seeking talented professionals excited to build new technology that advances scientific research while growing their career within a dynamic, supportive environment.
Sr. Quality Engineer
10x Genomics is seeking an outstanding Quality Engineer, who will be responsible for product quality support. In this cross functional quality role, you will be responsible in identifying, documenting, analyzing and reporting product quality issues, CAPA and NCs appropriately evaluated and resolved. You will ensure product and process conformance to applicable quality system requirement and standards. Also, will be responsible to ensure that business processes across the company are complaint with ISO9001:2015 standards.
Individuals applying for this position must be self-starters, strategic thinkers, action driven, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating across the organization and with external partners, and provide immediate contribution.
- Support product quality and manufacturing activities and is accountable for driving change, establishing effective and sustainable business processes (nonconformity, customer complaints and CAPA), improving product quality, and providing senior management with actionable data mining/analysis and status updates.
- Provide quality support for NPI activities including process and product transfer, and QC method validation, equipment and process qualification and facility validation, and product lifecycle management.
- Manages the execution of objectives for the control of external suppliers and contract manufacturers to assure the supply of acceptable quality of materials and product, resolve supplier quality issue and monitor supplier quality performance.
- Understand the applicable 10x technologies to participation in technical discussions, drive and facilitate product design and process risk management activities and coordinate issue resolution.
- Ensure that corporate business practices are compliant with IS09001:2015 or appropriate standards.
Required Skills and Background
- A scientific or engineering discipline relevant to 10x’s technologies and processes. Advanced degree preferred.
- Minimum 8 years' experience in the Life Science industry with direct experience supporting development and commercial quality systems in a Quality Assurance role.
- Practical experience in product quality management, quality and process improvement methodologies, failure investigation tools and techniques.
- Strong understanding and practice experience with product development and transfer (risk management, validation, NPI) and sustaining (change controls, CAPA).
- Strong collaboration and communication skills with colleagues and external collaborators.
Desired Skills and Background
- Experience with quality and statistical analysis tools (e.g. Risk Analysis, FMEA, DOE, SPC, Six Sigma)
- Hand on experience with electronic PLM, ERP, MES and enterprise Quality System tools.
- Quality certification desirable (e.g. CQM, CQE, CQA, RAC).
- Experience with ISO9001 or ISO 13485 quality systems in a Quality Assurance role.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.