Senior Product Complaints Analyst

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: Participate in product quality activities, including complaint investigations of company products. Facilitates cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated. Lead functional area initiatives as needed. Provide colleagues guidance and support as needed.

Identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner Support audits and/or inspections as needed Identify and lead product and process improvements to reduce complaints and cost of poor quality Actively participate on Quality and cross-functional project teams as needed  Provide direction, training, support and implementation of quality initiatives for the department Develop and maintain complaint process documentation and provide cross-functional training Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs Participate, facilitate, and/or support complaint investigations and resulting CAPA activities Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs) Provide support in the execution of field actions as applicable Provide management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion Write and critically review quality documents for internal and external distribution (e.g., investigation reports, SCAR responses, product quality notifications) and provide support and training to colleagues completing similar documents Participate and conduct tasks associated with rotational “monitoring” activities of QA mailbox All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Bachelor’s degree in an engineering or science discipline desired; advanced degree preferred   Quality Certification a plus (e.g., CQA, CQE)  Experience: 5-7 years’ experience in life sciences industry or research; direct experience working in medical device / in-vitro diagnostics (IVD) industry preferred Knowledge of quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDR) Exposure to complaint management, product development (design controls, risk analysis, validation) and post-market sustaining / maintenance (change controls, risk management, manufacturing quality, supplier management) Experience leading and/or managing cross-functional projects Skills: Use of Microsoft Office Products and standard office tools   Ability to multi-task in a fast-paced environment and manage changing priorities with a high degree of self-motivation  Good written, oral, and interpersonal English communication skills  Willingness to work in shifts to support the US region (No night shift required)  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