13 days old

Sr. Quality Engineer

US01 Illumina, Inc.
Hayward, CA 94541
  • Job Code
    19055-JOB

Responsibilities:

  • Provide ongoing quality engineering support throughout the product life cycle for multiple product platforms
  • Function as a project manager for global quality project integration efforts that impact the local quality systems
  • Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements
  • Provide quality support to engineering change controls, deviation management, and document change management
  • Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective/preventative actions
  • Provides quality support in the assessment and qualification of new supplier materials such as component specifications and inspection standards
  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
  • Provide quality consultation to end users and process owners with regard to data collection, analysis and creation of validation reports
  • Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
  • Review verification and validation reports and identify gaps for compliance to internal quality requirements
  • Develop and execute strategies to close quality gaps in an efficient, technical, and compliant manner
  • Coordinate issue resolution using a risk-based approach
  • Identify areas and opportunities to improve quality system processes and product issues
  • Ensure product development and validation programs meet internal quality requirements
  • 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
  • Own and/or coordinate CAPAs and NCRs
  • Coordinate investigations associated with supplier quality
  • Collaborate with the procurement, purchasing, and product design groups to assure compliance/quality of new vendors/materials
  • Other activities as assigned

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements:

  • Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, IVDR, MDSAP, and ASTM E2500-07 Verification Guideline)
  • Practical experience in design controls, risk management, validation, change control, and supplier quality
  • 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)
  • Highly effective communication, facilitation, coaching, and negotiation skills
  • Adaptable to fast-paced, dynamic work environment with shifting demands
  • 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

Experience/Education:

  • Typically requires a minimum of 5 years of related experience with a Bachelors degree; or equivalent work experience
  • 5+ years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
  • Quality Certification preferred (e.g., CQE)

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 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





Posted: 2019-11-23 Expires: 2019-12-22
Sponsored by:
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Sponsored by:
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Sr. Quality Engineer

US01 Illumina, Inc.
Hayward, CA 94541

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