Design Quality Engineer I
11 hours ago
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.
Summary
In this Design Quality Engineer I role, you will be a quality engineer on one or more product management teams expected to assist with assessments, evaluation, and implementation of design changes and processes for Illumina products driven by product risk management, post-market surveillance, components end of life, complaints, and other internal or market driven data. You will assist the teams with risk assessments, protocols writing, and documentation of results
Key Responsibilities
- Support of change management activities for on-market products
- Support of impact assessments for design, process, and risk control activities
- Review engineering reports for accuracy and presence of sufficient data to support the change
- Review change deliverables
- Support of Risk Management activities for on-market products
- Perform Product Risk Management File updates and reviews, as required
- Provide feedback into new product development as required
- Update and maintain Design History Files as needed
- Provide management with status updates on assigned responsibilities and goals - escalating issues and proposing solutions as necessary.
- Take initiative to identify and implement improvements to the Illumina quality system.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
**Qualifications**:
- Ability to quickly learn the principles behind Illumina technology, design, and manufacturing processes required
- Some experience in working in a regulated environment, in-vitro diagnostic, development, quality engineering and/or manufacturing (employment or internship) preferred
- Good writing and presentation skills required
- Knowledge and capability in one or more statistical analysis tools (JMP, R, Minitab, Tableau, SAS, etc.) preferred
- Practical experience in design controls, risk management, process controls, change management, and post market surveillance preferred
- Adaptable to fast-paced, dynamic work environment with shifting demands
- Less than 1 year no previous related experience; or equivalent work experience
**Education**:
Bachelor’s degree or higher (MS preferred) in technical field such as Chemistry, Biochemistry, Biomechanical Engineering, Physics, Mechanical Engineering etc.
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.
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