10x Genomics is seeking a Quality Engineer-Temp/Contractor, 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 requirements and standards. Also, will be responsible to ensure that business processes across the company are compliant 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.
What you will be doing:
- 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 input into MRBs
- Performs analysis and develop solutions to complex problems and drives process improvements, while considering many variables and understanding potential consequences
- Train internal auditors and manage internal audit program. In addition, perform internal audits.
- Support external audits
- Provide quality support for qualification and process and design validation activities
- Assist in complaint investigation and resolution.
- Monitor and act on Quality KPIs
- 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.
- A scientific or engineering degree relevant to 10x’s technologies and processes. Advanced degree preferred.
- 5 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.
- Strong problem solving and collaboration skills
- 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.
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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.