Product Complaint Specialist 2
Product Complaint Specialist 2
Posted on :
01-06-2025
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1 Vacancy
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Job Description
What if the work you did every day could impact the lives of people you know Or all of humanityAt 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.
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 To learn more visit: 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.
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 Illuminas 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:
- Bachelors 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 To learn more visit: 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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