Experience with CAPA and failure investigation tools and techniques
Experience using quality and statistical analysis tools including SPC, Six Sigma, Risk Analysis, FMEA, DOE, Trend Analysis
Ability to work in a fast-paced and dynamic environment
Demonstrated ability to work effectively across departments
Strong verbal and written communication skills
Ability to work independently with minimal supervision
Able to travel internationally
Skills
SPC
Six Sigma
FMEA
DOE
Trend Analysis
CAPA
ISO 13485
ISO 14971
21 CFR 820
IVDD
ISPE Baseline Guides
ASTM E2500-07
About the company
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
This position is involved in Supplier Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards, as well as Illumina product quality for current operations and compliance objectives.
Responsibilities
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Lead activities to improve material quality from suppliers, including corrective and preventive actions to ensure non-conforming parts do not enter Illumina.
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Manage and develop long-term supplier relationships with key sub-assembly suppliers to build their capability to meet Illumina’s quality requirements and expectations.
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Initiate supplier improvement projects, including: Process analysis Value stream mapping Process capability analysis Throughput analysis Six Sigma 5S Kaizen events
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Actively manage suppliers to ensure there are no regressions following implementation of new processes.
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Establish short-term and long-term supplier quality goals.
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Drive timely resolution of supplier quality issues to ensure continuity of supply.
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Assist in the evaluation and qualification of new suppliers and materials following the defined new product development process.
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Drive a “Zero Defect” mentality within the supply base.
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Develop new suppliers to meet Illumina’s quality and regulatory requirements and guide suppliers from conditional to acceptable status through improvement actions.
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Ensure supplier performance is regularly reported and appropriate corrective actions are implemented in a timely manner.
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Conduct supplier audits to verify compliance with QMS regulatory requirements, effective process controls, and Illumina requirements.
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Monitor, communicate, and improve key Supplier Quality metrics, including: SCAR Past Due KSPM Score Assembly Yield
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Travel to supplier locations to resolve quality problems.
Preferred Requirements
Nice to have
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8+ years of experience in a quality assurance field within a regulated environment; experience in IVD manufacturing preferred.
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Quality certification preferred (e.g., CQE).
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Experience applying quality regulations and standards including: 21 CFR 820 ISO 13485 ISO 14971 IVDD ISPE Baseline Guides ASTM E2500-07 Verification Guideline
Experience with CAPA and failure investigation tools and techniques.
•
Experience using quality and statistical analysis tools, including: SPC Six Sigma Risk Analysis FMEA DOE Trend Analysis
•
Ability to work in a fast-paced and dynamic environment.
•
Demonstrated ability to work effectively across departments.
•
Strong verbal and written communication skills.
•
Ability to work independently with minimal supervision.
•
Able to travel internationally.
Preferred Experience / Education
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Typically requires a minimum of: 8 years of related experience with a Bachelor’s degree; or 6 years of related experience with a Master’s degree; or 3 years of related experience with a PhD; or Equivalent experience.
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 [email protected]. 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.