Design Quality Engineer

Are you excited by building scalable quality systems that support next-generation genomics and regulated IVD products?

Do you thrive in an environment where quality, innovation, and cross-functional collaboration go hand in hand?

Are you looking for a role where your work directly impacts product quality, customer experience, and regulatory success across global markets?

Do you thrive in an environment with diversity, communication, collaboration, and teamwork as the core values?, The Design Quality Engineer will play a critical role in supporting the development, commercialization, and lifecycle management of next-generation sequencing and genomics products within a regulated quality environment. This role partners closely with R&D, Manufacturing, Operations, and Product teams to ensure quality is embedded throughout the product lifecycle-from development and validation through post-market support., * Quality Management System Support: Support and maintain QMS processes in alignment with ISO 13485 and applicable regulatory requirements

• Design Quality Activities: Partner with cross-functional teams on design controls, Design History File (DHF) maintenance, and product development quality activities
• Risk Management: Support risk analysis, risk control, and risk review activities in accordance with ISO 14971 methodologies
• CAPA & Nonconformance Management: Lead and support investigations, root cause analysis, corrective actions, and effectiveness verification activities
• Complaint Handling: Support customer complaint investigations, product quality trending, and post-market quality activities
• Validation Support: Coordinate and support IQ/OQ/PQ and process validation activities across manufacturing and development functions
• Audit Participation: Support internal audits, external audits, and regulatory inspection readiness activities
• Quality Data Analysis: Analyze complaints, CAPAs, NCRs, and audit findings to identify trends and drive continuous improvement initiatives
• Cross-Functional Collaboration: Work closely with R&D, Manufacturing, Operations, Product Management, and Regulatory teams to ensure quality objectives are achieved
• Supplier Quality Support: Assist with supplier qualification, supplier monitoring, and supplier quality activities as needed
• Documentation Review: Review and support approval of quality documents including SOPs, protocols, specifications, reports, and validation documentation
• Continuous Improvement: Help improve scalable quality processes supporting commercialization and manufacturing growth initiatives

WHERE YOU WILL WORK

• Headquarters Location: San Jose, California headquarters
• Work Environment: Primarily onsite role with collaboration across laboratory, manufacturing, engineering, and office environments
• Cross-Functional Exposure: Daily interaction with Quality, R&D, Manufacturing, Operations, and Product teams
• Travel Requirements: Occasional travel may be required for supplier audits, regulatory inspections, customer support activities, or conferences

This position will support Quality Management System (QMS) activities related to ISO 13485 and IVDR compliance while driving quality initiatives including CAPA, complaint handling, risk management, validation support, and continuous improvement efforts. The ideal candidate is hands-on, collaborative, detail-oriented, and comfortable operating in a fast-paced and evolving organization., * Regulatory Knowledge: Familiarity with ISO 13485, IVDR (EU 2017/746), and regulated quality system environments

• Quality Systems Experience: Experience supporting CAPA, nonconformance, complaint handling, audit, and validation activities
• Risk Management Knowledge: Understanding of risk management methodologies and ISO 14971 principles
• Validation Experience: Exposure to IQ/OQ/PQ, process validation, or manufacturing quality activities
• Technical Documentation Skills: Ability to review and maintain technical and quality documentation with strong attention to detail
• eQMS Familiarity: Experience working within electronic QMS or document management systems such as Arena preferred
• Analytical Skills: Strong problem-solving and data analysis capabilities using structured methodologies
• Microsoft Office Proficiency: Strong working knowledge of Word, Excel, PowerPoint, and related business tools
• Industry Background: Experience within medical device, diagnostics, biotechnology, genomics, or life sciences industries preferred, * Collaborative Mindset: You work effectively across technical and operational teams in a highly collaborative environment
• Adaptability: You are comfortable operating within a fast-paced and evolving organization
• Communication Skills: You communicate clearly and professionally across multiple organizational levels
• Ownership Mentality: You take initiative and proactively drive issues to resolution
• Attention to Detail: You maintain high standards for quality, documentation, and compliance accuracy
• Problem-Solving Approach: You approach challenges analytically and use structured thinking to identify practical solutions
• Continuous Improvement Focus: You are motivated by building scalable and efficient processes that improve operational quality, * Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical field
• 2-5 years of experience in Quality Engineering, Design Quality, or Quality Systems within regulated industries
• Experience within medical devices, IVD, diagnostics, biotechnology, or genomics environments preferred
• ASQ Certified Quality Engineer (CQE) certification is a plus

The base salary range for this position is $95,000 to $130,000, commensurate with experience, qualifications, and job responsibilities.

This position is eligible for an annual bonus program to recognize and reward your contributions and performance.

• Annual gym membership reimbursement to support your health and wellness
• Employee discount program to help you save on products and services

We offer eligible employees and their dependents (including domestic partners) a comprehensive and competitive benefits package. Complete Genomics contributes significantly toward employee benefits coverage.

Benefits include:

• Medical, Dental, and Vision Coverage
• Life and AD&D Insurance
• Long-term and Short-term Disability Insurance
• Voluntary Life and AD&D Insurance
• Health Savings Account (HSA)
• Flexible Spending Accounts (FSA)
• Domestic Partner Benefits
• Commuter Program
• Employee Assistance Program
• 401(k) Retirement Plan
• Education Assistance
• 20 PTO days and 11 paid holidays per year