Mfg/Ops Quality Engineer 2 at Illumina

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.

Responsibilities:

• 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

• Applies problem-solving techniques to define and resolve routine issues of moderate scope

• 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.

• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders

• Provide consultation to end users and process owners with regard to data collection, analysis and creation of reports.

• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making

• Coordinate issue resolution using a risk-based approach

• Identify areas and opportunities to improve quality system processes

• Ensure product development and validation programs meet requirements of FDA and ISO

• 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

• Other such duties that may be determined by Management.

Preferred Requirements:

• Quality related experience preferred
• Highly effective communication, facilitation, coaching, and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Ability to identify, assess, resolve and where needed, escalate risks
• Demonstrated ability to accomplish goals while working across departments is required.

All listed requirements 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
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis.

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.