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.

Minimum Qualifications:

• 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%

Preferred skills:

• 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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