Veracyte, Inc.
Sr. Quality Engineer, Design Control
Veracyte, Inc., San Francisco, California, United States, 94199
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but also to learn and grow within a purpose‑driven environment. This is what we call the Veracyte way – it’s about how we work together, guided by our values, to give clinicians the insights they need to help patients make life‑changing decisions.
Our Values
We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
We Care Deeply: We embrace our differences, do the right thing, and encourage each other
The Position As the Sr. Quality Engineer, Design Control, you will lead the design control activities across Veracyte’s IVD product lifecycle, ensuring compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other global regulatory requirements. This role will serve as the primary Quality partner to R&D and cross‑functional teams, driving robust design control execution, effective risk management, end‑to‑end traceability, and sustained audit readiness. The ideal candidate will bring hands‑on experience leading design control and risk management activities in a regulated IVD environment, including products developed under ISO 13485 and IVDR. This is a hybrid role (remote and in office at least 3 days a week) and is based out of our headquarters in South San Francisco, California.
Responsibilities
Serve as the QA lead on cross‑functional product development teams, ensuring design control requirements are incorporated from planning through commercialization.
Ensure compliance with all applicable standards, regulations, and internal SOPs throughout the design and development process and design changes; provide guidance on Quality System requirements related to design and development.
Lead risk management activities for projects under design control, ensuring compliance with internal procedures, ISO 14971, and applicable regulations; issue the Risk Management Plan and Report, lead cross‑functional risk management activities, and link risk to design changes and CAPAs.
Support design verification and validation activities by reviewing protocols and reports to confirm that design outputs meet design input requirements and that analytical and clinical performance is demonstrated; help resolve any discrepancies through root cause analysis and corrective actions.
Ensure ongoing design control compliance for design and post‑market changes, maintaining DHF integrity throughout product lifecycle.
Participate in internal and external audits, serving as the SME for design control and risk management, preparing audit responses, and leading remediation activities.
Proactively identify gaps in compliance and lead CAPA initiatives related to design control or development process issues.
Evaluate and implement process improvements to enhance efficiency, compliance, and scalability as Veracyte’s portfolio grows.
Develop metrics and KPIs related to design control effectiveness and compliance.
Qualifications
Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field.
7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry, with a strong focus on design controls and new product development; prior experience driving QA in cross‑functional product development teams is essential.
In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and ISO 14971:2019 risk management.
Hands‑on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control.
Demonstrated ability to review DHF documentation for compliance; comfortable interpreting engineering documentation, specifications, and test data for compliance.
Experience managing complex DHF structures digitally.
Experience with IVD assay lifecycle from development through commercialization.
Experience with SaMD or algorithm lifecycle management.
Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses.
Strong problem‑solving and organizational skills to manage multiple priorities.
Ability to work independently and proactively in a fast‑paced environment.
Attention to detail in understanding and documenting complex quality issues.
Relevant certification (e.g., ASQ Certified Quality Engineer, Six Sigma, ISO 13485 Lead Auditor) is a plus.
For Candidates Based in South San Francisco Office The salary or hourly range is
$138,000–$153,000 .
For Candidates Working Remote (US) The salary or hourly range is
$120,000–$135,000 .
Pay range USD 120,000—153,000
What We Can Offer You Veracyte offers competitive compensation and benefits, and is committed to fostering an inclusive workforce where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified Great Place to Work® in both the US and Israel.
About Veracyte Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with high‑value insights that guide and ensure patients at pivotal moments.
Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E‑Verify in the United States. View our CCPA Disclosure Notice.
If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to careers@veracyte.com.
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Our Values
We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
We Care Deeply: We embrace our differences, do the right thing, and encourage each other
The Position As the Sr. Quality Engineer, Design Control, you will lead the design control activities across Veracyte’s IVD product lifecycle, ensuring compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other global regulatory requirements. This role will serve as the primary Quality partner to R&D and cross‑functional teams, driving robust design control execution, effective risk management, end‑to‑end traceability, and sustained audit readiness. The ideal candidate will bring hands‑on experience leading design control and risk management activities in a regulated IVD environment, including products developed under ISO 13485 and IVDR. This is a hybrid role (remote and in office at least 3 days a week) and is based out of our headquarters in South San Francisco, California.
Responsibilities
Serve as the QA lead on cross‑functional product development teams, ensuring design control requirements are incorporated from planning through commercialization.
Ensure compliance with all applicable standards, regulations, and internal SOPs throughout the design and development process and design changes; provide guidance on Quality System requirements related to design and development.
Lead risk management activities for projects under design control, ensuring compliance with internal procedures, ISO 14971, and applicable regulations; issue the Risk Management Plan and Report, lead cross‑functional risk management activities, and link risk to design changes and CAPAs.
Support design verification and validation activities by reviewing protocols and reports to confirm that design outputs meet design input requirements and that analytical and clinical performance is demonstrated; help resolve any discrepancies through root cause analysis and corrective actions.
Ensure ongoing design control compliance for design and post‑market changes, maintaining DHF integrity throughout product lifecycle.
Participate in internal and external audits, serving as the SME for design control and risk management, preparing audit responses, and leading remediation activities.
Proactively identify gaps in compliance and lead CAPA initiatives related to design control or development process issues.
Evaluate and implement process improvements to enhance efficiency, compliance, and scalability as Veracyte’s portfolio grows.
Develop metrics and KPIs related to design control effectiveness and compliance.
Qualifications
Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field.
7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry, with a strong focus on design controls and new product development; prior experience driving QA in cross‑functional product development teams is essential.
In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and ISO 14971:2019 risk management.
Hands‑on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control.
Demonstrated ability to review DHF documentation for compliance; comfortable interpreting engineering documentation, specifications, and test data for compliance.
Experience managing complex DHF structures digitally.
Experience with IVD assay lifecycle from development through commercialization.
Experience with SaMD or algorithm lifecycle management.
Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses.
Strong problem‑solving and organizational skills to manage multiple priorities.
Ability to work independently and proactively in a fast‑paced environment.
Attention to detail in understanding and documenting complex quality issues.
Relevant certification (e.g., ASQ Certified Quality Engineer, Six Sigma, ISO 13485 Lead Auditor) is a plus.
For Candidates Based in South San Francisco Office The salary or hourly range is
$138,000–$153,000 .
For Candidates Working Remote (US) The salary or hourly range is
$120,000–$135,000 .
Pay range USD 120,000—153,000
What We Can Offer You Veracyte offers competitive compensation and benefits, and is committed to fostering an inclusive workforce where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified Great Place to Work® in both the US and Israel.
About Veracyte Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with high‑value insights that guide and ensure patients at pivotal moments.
Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E‑Verify in the United States. View our CCPA Disclosure Notice.
If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to careers@veracyte.com.
#J-18808-Ljbffr