Sr. Director Software Quality

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Position Summary:

As sequencing technology advances into clinical diagnostic and AI-driven applications the regulatory and quality requirements governing software have become as demanding as those governing physical devices. IEC 62304 compliance SaMD classification EU AI Act readiness and cybersecurity within the QMS are front-line regulatory risks.

The Sr Director Software Quality will establish and lead Illuminas standalone Software Quality function reporting directly to the VP of Global Quality. This leader will define the operating model build the team and own the end-to-end quality framework for all software products and software-driven medical devices across Illuminas global portfolio. The role requires deep technical expertise executive presence and the ability to work cross-functionally with R&D Regulatory Affairs and Commercial to ensure software quality is embedded from design through post-market surveillance.

Responsibilities:

Build and lead the Software Quality function

Establish Illuminas standalone Software Quality organization - defining structure headcount roles and operating model

Recruit develop and retain a high-performing team of software quality engineers with depth in IEC 62304 SaMD risk management and cybersecurity

Serve as the primary quality authority for all software products software-driven IVDs and AI/ML-enabled diagnostic tools across the global portfolio

Own the regulatory and compliance framework for software

Define and own Illuminas global Software Quality Management System (SQMS) in alignment with IEC 62304 ISO 14971 ISO 13485 and QMSR (21 CFR Part 820)

Lead the implementation and ongoing compliance of the EU AI Act quality and risk management requirements for AI/ML-enabled products

Ensure all software products are correctly classified under SaMD frameworks (IMDRF FDA Software Guidance) and that quality requirements are appropriately applied

Drive IECand cybersecurity-in-the-QMS implementation and maintenance activities

Embed software quality into the product development lifecycle

Partner with R&D to integrate software quality checkpoints into the Product Development Process (PDP): stage gates design reviews and risk assessments Own software-specific DFMEA hazard analysis and software risk management file requirements across IVD and RUO product lines

Define and enforce software verification and validation (V&V) standards across all development teams

Collaborate with Design Quality to maintain clear delineation between hardware and software quality responsibilities within the PDP

Lead post-market software quality oversight

Establish software-specific post-market surveillance (PMS) processes including software update monitoring cybersecurity vulnerability tracking and SOUP (Software of Unknown Provenance) management

Own the software CAPA process in collaboration with the Global Quality Ops team ensuring software-origin findings are root-caused and resolved with appropriate rigor

Manage software-related complaint investigations and MDR/vigilance reporting obligations in partnership with the Complaints and PMS function

Operate as a senior quality leader

Serve as the subject matter expert for software quality in regulatory inspections (FDA BSI MDSAP KFDA PMDA NMPA) and respond to observations requiring software quality remediation

Represent Software Quality on the monthly Quality Council and contribute to the quarterly Executive Quality Council

Build strong working relationships with VP-level leaders across R&D Regulatory Affairs Commercial and Operations

Stay ahead of the regulatory landscape: EU AI Act implementation timelines IMDRF SaMD updates FDA cybersecurity guidance and translate changes into proactive QMS updates

Requirements:

Technical expertise

IEC 62304: Deep hands-on expertise in software lifecycle processes not just awareness but the ability to define implement and audit compliance

SaMD classification and risk management: Demonstrated experience with IMDRF FDA and EU MDR/IVDR frameworks

EU AI Act Working knowledge of requirements as they apply to medical device AI/ML software including risk classification technical documentation and transparency obligations. Proficiency in cybersecurity within the QMS context: IECTIR 57 TIR 97 and SOUP management

ISO 14971 Strong foundation in risk management as applied to software and ISO 13485 quality system requirements. Familiarity with software V&V methodologies unit testing frameworks software configuration management and CI/CD quality integration

Leadership and organizational experience

Proven track record building and leading software quality teams in a regulated medical device or IVD environment

Experience operating at the Sr Director level with direct accountability to senior quality or regulatory leadership

Demonstrated ability to influence cross-functional stakeholders including: engineering product management and regulatory without direct authority

Track record of building quality systems from the ground up not just inheriting and maintaining existing ones

Strong executive presence with the ability to communicate complex software risk clearly to non-technical leadership

Inspection and audit readiness

Experience representing software quality in FDA BSI MDSAP or equivalent international regulatory inspections

Comfortable owning software-related observations and CAPA responses including interaction with regulatory bodies

All listed requirements are deemed as essential functions to this position; however business conditions may require reasonable accommodations for additional task and responsibilities.

Experience/Education:

Bachelors degree in Software Engineering Computer Science Biomedical Engineering or a related technical discipline required; advanced degree preferred

20 years of experience in software quality software engineering or a closely related function in the medical device or IVD industry

10 years of leadership experience managing software quality teams or programs

Experience in both NPI (new product introduction) and on-market sustaining software quality preferred

Certifications desirable: CSQE (Certified Software Quality Engineer) CSSLP (Certified Secure Software Lifecycle Professional) or equivalent

The estimated base salary range for the Sr. Director Software Quality role based in the United States of America is: $205100 - $307700. Should the level or location of the role change during the hiring process the applicable base pay range may be updated accordingly. The range reflects longterm growth in the role. Most candidates are hired between the minimum and middle of the range. Placement depends on experience skills location and internal equity. Additionally all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work including access to genomics sequencing family planning health/dental/vision retirement benefits and paid time off.

We are a company deeply rooted in belonging promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation Illumina has always prioritized openness collaboration and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay regardless of gender ethnicity or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences increase cultural awareness and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex race creed color gender religion marital status domestic partner status age national origin or ancestry physical or mental disability medical condition sexual orientation pregnancy military or veteran status citizenship status and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local state and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local state and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process please contact To learn more visit: The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.