All About Us
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.
We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.
All About You
In this role, the individual will actively participate in CAPA and manufacturing Non- conformance program and activities ensuring product and process conformance to FDA, ISO 13485 and other global quality standards as they apply to products distributed for research and diagnostic use.
This role will serve as a Global technical resource to develop sustainable business process improvements and solutions related to health and compliance of the CAPA and Nonconformance programs to ensure field and internal product quality issues are being identified and escalated into these system, and also properly trended and investigated.
This individual could be involved in initiatives to improve the guidelines and policies related to NC and CAPA programs to ensure improved product quality, reliability, and customer experience with Illumina’s marketed products.
Also the candidate could be responsible for developing Failure Investigation and Quality Event process, CAPA and NC risk determination strategies and tools and conducting training to those processes to improve the inputs and output of these two programs and to enhance internal customer’s experiences with these systems.
The person in this role will facilitate discussions in identifying, documenting, analyzing and reporting quality events and ensuring that the elevated issues from multiple sources are appropriately evaluated and triaged into appropriate subsystems such as CAPA system.
This role requires strong collaboration, communication, interpersonal and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards as they apply to domestic and international products distributed for research and diagnostic use.
- Ensures adequacy of non-conformances and CAPA system, practices as well as records, investigations, and corrective actions.
- Identifies product and process trends and drive improvements to reduce complaints, non-conformances and cost of poor quality.
- Collaborates deeply with other Illumina sites and partners to implement new processes and also promotes awareness and adherence to policy and procedures
- Responsible for the enhancement of NC and CAPA data mining/ analysis for the purpose of identification, escalation and containment of internal and field product quality issues.
- Represents NC and CAPA areas as a subject matter expert in support of audits.
- Participates in enhancement of NC and CAPA track and trend, risk determination, failure investigation/ root cause analysis and other improvement projects to advance processes and their capabilities.
- Develop and monitors process metrics and action plans as needed.
- Provides recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs.
- Provides management with status updates on assigned responsibilities and goals and escalates issues with respect to these responsibilities and goals in a timely fashion.
- Other such duties that may be determined by Management.
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.
- 5-10 years of experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred.
- Experience applying quality regulations and standard as well as Risk Management standards and practices (21CFR 820, ISO 13485, ISO 14971, IVDD).
- Recent strong experience in handling non-conforming product, investigation methodologies and root cause analysis techniques associated with product and process failures and data mining and analysis from relevant Quality system databases.
- Practical experience in Process improvement, risk management, validation, change control, and supplier quality.
- Experience with CAPA and failure investigation and root cause analysis tools and techniques as well as relevant
- Knowledge of applicable regulatory requirements e.g. QSR 803 and 806 as well as IVDD is preferred.
- Strong organizational and task management skillsets is required for this position.
- Applied experience with quality and statistical analysis tools (SPC, Risk Analysis, FMEA, DOE, trend analysis).
- Excellent interpersonal, verbal and written communication skills.
- Excellent attention to detail, well organized and able to work independently and in teams.
- Strong critical thinking and problem solving skillsets is required in this role.
- Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
- Demonstrated ability to accomplish goals while working across departments is required
- Proven experience working with complex Quality System Databases and ERP systems.
- Highly skilled in MS word, Excel, Microsoft Visio, to conduct data analysis/ data trending and assist in developing process maps and procedures.
- Bachelor’s degree in an engineering or science discipline; advanced degree preferred.
- Quality Certification preferred (e.g., CQE).
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