Illumina
genomic technology
Mfg/OpsQualityEngineer2
Neural analysis suggests this role is
optimal for Mid candidates.
“Mfg/Ops Quality Engineer 2 at Illumina. Skills: quality engineering support, risk management, validation, change control, CAPA, failure investigation, statistical analysis. Provide quality engineering support throughout the product life cycle.. Provide support to engineering and manufacturing functions.”
What You'll Achieve.
realize health equity for billions of people around the world; enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients; make a difference; do more and become more than you ever thought possible; Drive activities in prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.; Ensure product development and validation programs meet requirements of FDA and ISO; improve product and develop recommendations based on data analysis
Industry & Context.
Applies problem-solving techniques to define and resolve routine issues of moderate scope; risk-based approach; failure investigation tools and techniques
What They're Looking For.
Must Have
Quality related experience preferred, 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)
Nice to Have
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
What You'll Do.
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
guidance and interpretation as needed.
Drive product risk management activities and ensure quality and completeness of project design history files
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
and outcomes are appropriate and are clearly documented and communicated
and report on quality data in order to improve product and develop recommendations based on data analysis
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
How You'll Work.
Team & Collaboration
Provide support to engineering and manufacturing functions.; Work with project teams to ensure understanding of and compliance with regulations, procedures, and requirements.; 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; Demonstrated ability to accomplish goals while working across departments is required.
Communication Scope
Highly effective communication, facilitation, coaching, and negotiation skills; Provide training, guidance and interpretation as needed.; Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Process & Methodology
Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
Full Job Description
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 *
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