Compliance Engineer at Illumina, Inc.
Posted in Architecture 30+ days ago.
This job brought to you by eQuest
Location: Madison, Wisconsin
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. Life at Illumina is about working with teammates who 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. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.
In this role, the individual will actively participate in CAPA and Nonconformance program activities within the Illumina-Madison Operations department, 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 technical resource to ensure product and process quality issues are being identified and escalated into these systems, and also properly trended and investigated.
This individual will be involved in initiatives to improve the procedures, guidelines and policies to ensure improved product quality for components and finished goods made in Madison, WI.
The person in this role will facilitate discussions in identifying, documenting, analyzing and reporting product quality issues and ensuring that they are appropriately evaluated and triaged into appropriate Quality processes such as the Nonconformance and/or CAPA systems. This individual would also support implementation of corrections and corrective actions.
This role requires strong collaboration, communication, interpersonal and organizational skills and a solid understanding of operational excellence tools such as Root Cause Analysis, A3, Pareto, SPC, PDSA, etc.
- Identifies product and process trends and drive improvements to reduce complaints, non-conformance and cost of poor quality.
- Responsible for the enhancement of NC and CAPA data mining/ analysis for the purpose of identification, escalation and containment of internal product quality issues.
- Participates in enhancement of NC and CAPA track and trend, risk based approach and solutions, risk determination, failure investigation/root cause analysis and other improvement projects to advance Operations departmental processes, products and their capabilities.
- Develop and monitors Operations departmental process metrics and action plans for improvement projects.
- 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 an operations function in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred.
- Recent strong experience in 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.
- 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. (Example: SAP, EtQ)
- 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.
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. If you have a disability or special need that requires accommodation, please contact us at 858-255-5081. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf