Sr. Quality Engineer - Complaint Handling
Would you like to join an innovative team creating technology to power groundbreaking insights in academic, clinical, pharma and biotech research?
It is an extraordinary time for Fluidigm. Our technology is empowering customers to improve life through comprehensive health insight. We invite you to join a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.
At Fluidigm we are also building a positive culture where our people can do the best work of their careers, informed and influenced by our core values:
- Create what customers need next.
- Drive to make a difference.
- Collaborate and learn.
- Step up.
Fluidigm is looking for a Sr. Quality Engineer – Complaint Handling to join our team. Now is an exciting time for Fluidigm, and we want you to join us! We have placed our first In Vitro Diagnostic product on market and have pipeline of new products planned to make an impactful difference in clinical diagnostics. The quality and regulatory organization at Fluidigm is a cohesive group of professionals who enjoy what they do and have fun doing it! We invite all candidates who meet the qualifications below to apply for the opportunity to contribute to a dynamic and growing team.
- Oversees the reagent batch record review and product disposition program.
- Performs technical review of executed manufacturing batch records for accuracy, clarity, consistency, completeness, and compliance to specifications.
- Opens nonconformances, as needed, and assists the manufacturing team with investigation, root cause analysis, action planning and nonconformance disposition.
- Determines in-process and finished good disposition.
- Manages equipment for the South San Francisco site. This includes maintaining equipment records, approving new equipment, reviewing calibration and maintenance records.
- Serves as QA resource for creation and review of equipment validation activities, including DQ/IQ/OQ/PQ plans and reports.
- Assists with CAPAs and nonconformances, as assigned.
- Participates as an internal auditor, performing audits as assigned by the Audit Coordinator.
- Assist with the continuous improvement of the Fluidigm Quality Management System at the SSF site and across other sites.
- Technical Degree (BS or higher) in a biological or chemical science and 2-5 years of Quality Assurance or Quality Control experience in an ISO 13485 and FDA registered manufacturing facility.
- Prior experience with IVD reagents preferred.
- Experience with record review and product disposition preferred.
- Experience with equipment qualification (DQ/IQ/OQ/PQ) preferred.
- ISO 13485:2016 lead auditor certification a plus.
- The ability to work across the organization with all levels of employees to ensure that the value of the Quality Programs are understood and embraced.
- Ability to work in a dynamic & fast paced environment with multiple stakeholders.
Ready to join an industry leader with a bold and ambitious mission that is enabling advancements in human health? Apply online with your resume!
Fluidigm is an equal opportunity/affirmative action employer. We will consider all qualified applicants for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.