Position Summary:
This role is responsible to ensure that 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, non-conformance, customer complaints, risk assessment and support maintenance of the QMS.
Position Responsibilities:
Serve as Quality representative on project teams for new product transfers
Review and approve manufacturing operational activities, such as Device History Records (DHR), nonconformance, CAPA, RMA, and customer complaints
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
Ensure the quality systems meet customer, corporate, or internal requirements and any other related requirement within the Quality Management System
Participate in management of corrective action program (customer complaints) to ensure timely follow-up, completion and documentation of corrective actions
Manage customer complaints and work closely with cross function in issue investigation and ensure timely response of to corporate/ customer
Work in accordance with procedures and integrated program plans for achieving and maintaining 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.
Position Requirements:
Bachelor’s degree in Engineering or Biological/Life Sciences or equivalent field
Minimum 5 years of experience in a medical device manufacturing environment.
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
Experience with statistical analysis packages, e.g. JMP, Minitab is highly preferred
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative 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 offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. 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. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.