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Illumina

Senior Manager, Design Quality

Location
San Diego, CA (CA)
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Manufacturing/Quality
Industry
HealthTech/Diagnostics
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From the employer's posting

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary

The Senior Manager, Design Quality is a hands-on Quality leader who combines supervisory responsibilities with direct Design Quality support for product-development programs. The role leads and develops a team of Design Quality professionals while partnering with Product Development to establish fit-for-purpose Quality strategies, identify and address risk early, and ensure development decisions are supported by appropriate technical evidence and rigor.

Responsibilities

The Senior Manager is accountable for effective Design Quality execution across assigned programs, including product risk management, design controls, verification and validation, design transfer, process validation, change management, and resolution of product quality issues. The role provides direct technical Quality leadership on assigned programs while aligning Design Quality resources with business and portfolio priorities.

The Senior Manager builds a high-performing Design Quality organization by developing technical and leadership capability, strengthening cross-functional partnerships, ensuring significant risks are appropriately addressed and escalated, and continuously improving the effectiveness of Design Quality practices and the Quality System.

Changes to individual responsibilities may occur due to business needs, and other related duties may be assigned.

Scope of Responsibilities

  • Supervisory and direct project leadership: Combines leadership of Design Quality professionals with direct support of product-development programs and other priority work. Provides coaching, technical guidance, independent Quality challenge, document review and approval, and timely resolution of complex product and Quality issues.
  • Design Quality strategy and execution: Establishes fit-for-purpose Quality strategies and enables effective execution across product-development programs, including design planning, requirements, design reviews, verification and validation, design transfer, process validation, change management, and resolution of product quality issues.
  • Product risk management: Leads and supports activities to ensure product risks are identified, evaluated, controlled, communicated, and appropriately documented throughout development. Ensures risk-management strategies and evidence support product and program decisions.
  • Technical Quality leadership: Ensures development strategies and decisions are supported by appropriate technical evidence, Quality rigor, statistical methods, and risk-based rationale. Provides independent Quality direction and challenge for complex, ambiguous, or high-risk issues.
  • People and organizational leadership: Builds and sustains a high-performing Design Quality team through effective coaching, performance management, technical development, succession planning, cross-training, and meaningful development opportunities. Establishes clear objectives, expectations, and accountability for results.
  • Resource and priority management: Aligns Design Quality resources and individual assignments with business, portfolio, and program priorities while balancing supervisory responsibilities, direct project support, and emerging Quality risks.
  • Cross-functional leadership and influence: Partners across Product Development and Quality functions to resolve complex issues, establish clear roles and decision rights, and drive timely, technically sound, compliant, and risk-informed decisions.
  • Quality governance and escalation: Ensures significant product, compliance, Quality System, and program risks are visible, appropriately escalated, and driven to resolution. Represents Design Quality in cross-functional governance forums and communicates clear, evidence-based recommendations to senior leadership.
  • Quality System and continuous improvement: Drives effective and consistent Design Quality practices, ensures appropriate evidence of product and Quality System compliance and readiness, and improves processes, procedures, tools, and methods that strengthen Design Quality performance.


Education / Experience

Typically requires a Bachelor’s degree and a minimum of 12 years of related experience, with 3-6 years of Management experience.

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