Basic Function and Scope of the Position:
The Engineer, Quality, ensures 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, new production introduction, risk assessment and support maintenance of the QMS.
Tasks and Responsibilities:
Provide quality assurance support, review and approval to areas of manufacturing operations, product development, or field/ product quality.
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 complaint investigations.
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.
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.
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.
Preferred Educational Background:
Bachelor’s degree in Electrical Engineering or Life Sciences.
Preferred Experiential Background:
1-3 years in manufacturing, quality assurance, and/or process validation in a regulated environment.
Experience in the medical device/IVD or biotech/pharmaceutical industry is an advantage.
Excellent interpersonal, verbal and written communication skills.
Familiar with 21 CFR 820 and ISO 13485 requirements
Ability to multi-task and methodically manage projects in a fast-paced manufacturing environment.
Familiar with words processing, spreadsheets and presentation tools.
Familiar with failure investigation, technical report writing, data mining, trend analysis and statistical analysis
Strong attention to detail
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.