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 Bachelor’s 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)
Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.
At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and 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 demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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