Senior Manager Software Quality

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.

Responsibilities:

• Leading a team to accomplish objectives with energy and enthusiasm
• Is an experienced subject matter expert within Software Quality Engineering
• Able to lead inter-disciplinary investigation and resolution of problems in Software and Design Quality Engineering
• Manages content knowledge within Software Quality Engineering and recommends improvements
• Executes and achieves results for internal and external customers in an efficient and effective manner
• Receives departmental objectives with goals and targets and translates those to the team
• Plans activities at team level to meet operational needs.
• Takes direction regarding budget and resource allocation
• Balances effective utilization of direct reports within project and design quality plans
• Models personal accountability to goals and objectives.
• Grows and develops a high performing design quality team that can readily adapt to meet the changing needs of the organization
• Coaches team members proactively to support skill development and career growth, leveraging formal resources and informal conversations
• Refines existing processes to improve department effectiveness
• Collaborates and works with others (up, down and across the organization) in a way that brings the best thinking forward
• Builds and maintains positive relationships with team members within Software and Design Quality and with internal stakeholders
• Collaborates effectively outside the department and across sites to achieve departmental goals
• Manages effectively onsite and project-focused employees

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

• Expert knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices Design Controls, Risk Management, Verification and Validation
• A solid understanding of the application of regulations and standards (21CFR 820, IVDD/IVDR, ISO 13485, ISO 14971, IEC62304)
• Experience with Clinical Trials/Evaluations, GxP, Auditing and CROs is a plus.
• Experience with post market activities (complaint handling / failure investigations)
• Excellent written and oral communication skills
• Comprehend technical reports and specification documents
• Review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write concise and accurate reports and give oral presentations
• Self-motivated, strong leadership skills with demonstrated ability to guide and influence medium sized teams effectively
• Working across teams and functions, managing and escalating risk
• Excellent organizational skills and able to work cross-functionally
• Hands-on experience with Next Generation Sequencing consumables and chemistry preferred
• Hands-on experience with Software used in Next Generation Sequencing products preferred
• Occasional travel may be required

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:

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