CG
Design Quality Engineer
Accepting applicationsComplete Genomics · San Jose, CA
Full-Time Mid_senior aiateganrf
Posted
6h ago
Category
Test
Experience
Mid_senior
Country
United States
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?
ROLE SUMMARY
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.
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.
WHAT YOU WILL BE DOING
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
WHAT YOU WILL BRING US
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
ABOUT YOU
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
WHAT YOUR EDUCATION LOOKS LIKE
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
HOW WE WILL REWARD YOU
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
EQUAL EMPLOYMENT OPPORTUNITY
Complete Genomics is an Equal Opportunity Employer committed to creating a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law.
Show more Show less
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?
ROLE SUMMARY
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.
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.
WHAT YOU WILL BE DOING
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
WHAT YOU WILL BRING US
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
ABOUT YOU
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
WHAT YOUR EDUCATION LOOKS LIKE
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
HOW WE WILL REWARD YOU
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
EQUAL EMPLOYMENT OPPORTUNITY
Complete Genomics is an Equal Opportunity Employer committed to creating a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law.
Show more Show less