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:
In this cross functional Quality role, the Complaint Specialist II will be responsible for processing complaints related to on-market medical devices. Participate in complaint handling activities, such as complaint record review and closure and participate in escalated complaint investigation, as needed, as part of Illumina’s Quality Complaint Handling Unit.
This position is responsible for processing complaints which includes, documenting, evaluating and facilitating cross functional discussions with SMEs and ensuring that customer feedback is appropriately evaluated. Provide colleagues support as needed. Job Requires a willingness to work in shifts to support the US region (No night shift required ).
Responsibilities:
- Conduct review of complaints for regulated products in a timely manner.
- Identify, and triage potential adverse events and/or field actions and escalate to the QA Complaint leadership team in a timely manner
- Participate in monitoring the QA Complaint Handling inbox and conduct tasks associated with rotational “monitor” activities
- Ensure adequacy and accuracy of complaint records
- Support Global complaints for case handling audits, when necessary
- Complete other activities as assigned
Education:
- Bachelor’s degree in an engineering or science discipline desired; advanced degree preferred
- Quality Certification a plus (e.g., CQA, CQE)
Experience:
- Minimum 2 years’ experience in complaint handling or direct experience working in medical device / in-vitro diagnostics (IVD) industry preferred
- Knowledge and/or experience using Electronic Quality Management System for Complaint Handling is preferred
- Good Documentation Practice (GDP) experience
- Familiar with quality regulations and standards (21CFR820, ISO 13485, ISO 14971, and/or IVDD)
Required Skills:
- Use of Microsoft Office Products and standard office equipment
- 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
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.
