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
The Mfg/Ops Quality Engineer 2 is responsible for support and leadership of Quality Engineering activities in Life Cycle Engineering, New Product Development, CAPA, and process improvement activities. In this role, you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This role will serve as a resource to product development and manufacturing to improve product quality, reliability and process capability.
Position Responsibilities
- Apply problem-solving techniques to define and resolve routine issues of moderate scope
- Provide quality engineering support throughout the product life cycle
- Provide support to engineering and manufacturing functions. Assist teams in determining issue resolutions using a risk-based approach
- Provide support to moderate scope activities where analysis of situations or data requires a review of a variety of factors
- Consistent application of quality policies & procedures in product design & development, secondary development & transfer operations
- Drive activities in prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Work with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
- Identify areas and opportunities to improve quality system processes
- Participate in investigations and ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education
- Bachelor’s Degree in Engineering, Science, or other related field required (or equivalent combination of education and experience)
- 3+ years’ experience in quality assurance field, in a regulated environment
- Experience applying quality regulation standards (e.g. 21CFR820, ISO 13485, ISO 14971, IVDD)
- Practical experience in risk management, validation, change control etc
- Experience with CAPA and failure investigation tools and techniques
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.
