Product Complaint Specialist II
Job Summary
Job Description
- Minimum 2 years of experience in complaint handling or medical device/IVD industry
- Good Documentation Practice (GDP) experience
- Familiarity with quality regulations and standards
- Proficiency in Microsoft Office Products
- Ability to multi-task and manage changing priorities
- Good written, oral, and interpersonal English communication skills
- Bachelor's degree in engineering or science
- Advanced degree preferred
- Quality Certification (e.g., CQA, CQE)
- Experience with Electronic Quality Management System for Complaint Handling
5 skills required
Job Details
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
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 accommodations@illumina.com. 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.
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About The Company
At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.
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