Senior Quality Engineer

Senior Quality Engineer

This Senior Quality Engineer is responsible for supporting and implementing improvement activities and projects. Provides QA support to stakeholders across a range of Quality processes. Responsibilities include Risk Management, Audit management, and continuous improvement.

Why Us?

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.

Illumina's employee benefits are industry-leading and include flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more!

Responsibilities:

• Assignments may include areas such as Risk Management, Audit management, non-conformances, deviations, material control, product release, CAPA/complaint handling, investigations, and EQA.
• Actively participate on Quality teams and cross-functional project teams as needed
• Identifies product and process improvements to reduce complaints and cost of poor quality
• Provides recommendations for improvements as they are identified during the analysis, tracking, and trending of quality review inputs
• Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval, and determination of on-going needs
• Monitor and interpret new and existing standards and regulations and implement solutions to maintain compliance.
• Participate as the subject matter expert during audits and/or inspections as needed
• Promotes global awareness and provides training to policy and procedures
• May be responsible for maintenance of local work instructions, SOPs and training of Quality Engineers and Associates.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion
• Trend, analyze, and report on quality data to improve products and processes.
• 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. Changes to individual responsibilities may occur due to business needs.

Preferred Requirements:

• Experience in a regulated environment, ideally medical laboratory testing, medical device development, or other regulated industry.
• Strong knowledge of ISO standards such as ISO 15189, ISO 17025, ISO 13485
• Excellent attention to detail, well organized, able to work independently and with a team, and provide SME leadership.
• Interpersonal, verbal, and written communication skills and ability to establish relationships across functions and different levels.

Experience/Education:

• Typically requires a university degree and several years of related experience.

What can you expect?

Our team members are bright, energetic, and dedicated - they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.