Senior Quality Engineer- Not Software
10x is seeking a Senior Quality Engineer, who will be a member of the Global Quality organization, reporting to the Senior Director of Global Quality and Document Control. In this cross functional quality role, you will be responsible for 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, you will be responsible to ensure that business processes across the company are compliant with ISO9001,ISO13485, and FDA 21 CFR part 820 Standards.
What you will be doing:
- Support product quality and manufacturing activities and are 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, as well as ongoing sustaining operations.
- Manages the execution of objectives for the control of internal and external suppliers and contract manufacturers to assure the supply of acceptable quality of materials and product, resolve supplier quality issues and monitor supplier quality performance, and maintains associated metrics (NCs, Audits, Audit Actions, SCARs).
- Aides in the assessment and qualification of new supplier materials such as raw materials, component specifications and inspection standards. Identify opportunities for reduced inspection of purchased materials based on risk and 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, ISO13485, FDA 21 CFR part 820.
- A scientific or engineering degree relevant to 10x’s technologies and processes.
- Minimum 8+ years' experience in life science or medical device manufacturing with direct experience in instrument, chemical, biological, and related supplier management.
- Experience with quality and statistical analysis tools (e.g. Risk Analysis, FMEA, DOE, SPC, Six Sigma)
- Direct experience supporting development and commercial quality systems in a Quality Assurance and/or Quality Engineering 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.
- Experience with ISO9001
- Ability to travel up to 25%
- Advanced degree preferred.
- Hand on experience with electronic PLM, ERP, MES and enterprise Quality System tools.
- Quality certification desirable (e.g. CQM, CQE, CQA, RAC).
- Experience with ISO 13485, and FDA 21 CFR part 820 quality systems in a Quality Assurance/Quality Engineering role.
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Below is the base pay range for this full time position. The actual base pay will depend on several factors unique to each candidate, including one’s skills, qualifications, and experience. At 10x, base pay is also just one component of the Company’s total compensation package. This role is also eligible for 10x’s equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program. Your 10x recruiter can share more about the Company’s total compensation package during the hiring process.
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.