Senior Quality Engineer

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.

Draft copy of Job Description also attached.

Position Summary:

This position is responsible for Supplier Quality and Channel Partner audit activities on behalf the Europe region. The role also provides support for analytics for the Europe Quality team. By proactively reviewing regional data to identify trends and recommend updates or changes to drive improvements. Participates in continuous improvement activities of Illumina’s Suppliers, Channel Partners and purchasing controls.  This role will require collaboration with colleagues in EMEA and AMR.

Changes to individual responsibilities may occur due to business needs.

Responsibilities:

• Acts as Lead auditor for Supplier and Channel Partner audits in Europe, supporting the global programs.
• Leads regional follow up activities to drive process standardization and continuous improvement for Supplier & Channel Partner programs
• Responsible for leading evaluation and qualification activities of Suppliers.
• Create, manage, and monitor Europe Quality data reports in collaboration with colleagues.
• Perform exploratory data analysis to understand the current state, existing opportunities, and potential future enhancements and solutions, as well as being able to summarize and present results to the leadership
• Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
• Ability to provide training to other team members to ensure consistency and compliance to processes and procedures where applicable.
• Other such duties that may be determined by Management.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.

Requirements:

• Experience conducting compliance audits, experience with auditing suppliers preferred.
• Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) & Root Cause Analysis.
• Excellent attention to detail, well organized and able to work independently and in teams.
• Experience in Data Analysis techniques.
• Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.
• Experience with electronic product life cycle (PLM) systems such as Agile, SAP or other PLM systems.
• Practical experience in FDA and ISO regulated environments is preferred.
• Ability to travel domestically and internationally as needed.

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

Experience/Education:

• Bachelors Degree or equivalent in a technical discipline with 5+ years of experience.
• Experience working in a regulated environment, in-vitro diagnostics preferred.

Illumina believes that everyone has the ability to make an impact, and 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.