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.

Responsibilities:

• 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.

Education:

• 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 in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.