The Senior Engineer, Quality, is responsible to ensure design transfer and manufacturing operations activities are executed in compliance with Illumina’s established Quality Management System (QMS) and relevant international/national regulations. These activities include, but are not limited to, validation, nonconformance, customer complaints, risk assessment and support maintenance of the QMS.
All About You
Provide quality assurance support, review and approvals to areas of manufacturing operations, product development, or field/ product quality.
Ensure that facilities, equipment, materials, processes, procedures and product readiness to comply with cGMP practices
Serve as Quality representative on project teams for new product design transfers and/or line transfers
Review and approve manufacturing operational activities, such as Work Instructions, Device History Records, Nonconformance, CAPA, RMA, and customer complaints.
Review and approve validation protocols and reports; ensure compliance with established procedures and sound validation methodology.
Work with cross-functional teams to resolve operational quality issues.
Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary.
Participate in investigations and ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated
Manage customer complaints and work closely with cross-functional teams to investigation issue and ensure timely response to corporate/ customer.
Work in accordance with procedures and integrated program plans to achieve and maintain the required level of product quality in preparation for FDA and ISO third party audits.
Train new engineers and/or associates
Other such duties that may be determined by Supervisor.
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.
5-7 years in manufacturing, quality assurance, and/or process validation in a regulated environment.
Experience in the medical device/IVD or biotech/pharmaceuticalindustry; experience in instrument hardware and software systems integration is an advantage.
Excellent interpersonal, verbal and written communication skills.
Ability to apply experience to meet 21 CFR 820 and ISO 13485 requirements
Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus
Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis
Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
Proficient in computer systems such as Microsoft Office & SAP.
May have experience with statistical analysis packages, eg, JMP, minitab
Bachelor’s degree in Electrical Engineering or Biological/Life Sciences.
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.