Sr. Quality Engineer, Design Control

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, ISOand 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 ISOand 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 (EUand 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…