Basic Function and Scope of the Position:
The Quality Ops Analyst 2 is the Calibration & Maintenance Coordinator for the Hayward site. You are responsible for control of monitoring, measuring, inspection, and test equipment, to ensure that equipment is suitable for its intended purpose and can produce valid results, while ensuring that the requirements for calibrating, inspecting, and maintaining equipment are fully satisfied.
Based on the needs of the organization, the incumbent may also be assigned to, coordinate, and/or support one or more of the following processes:
- Device History Record Review - Review of batch record and product release. May be involved in the development, implementation, and maintenance of Quality System processes to meet the requirements of FDA 21 CFR 820, ISO 13485, and other applicable quality and regulatory standards.
- Incoming Quality Control - perform moderate to complex visual and mechanical inspections of purchased components, sub-assemblies, and materials for first article and routine inspections.
- Return Material Authorization - ensure instruments, components, and consumables returned to Illumina are properly classified, dispositioned, and processed.
- Supports Internal/External Quality Audit activities and other key quality initiatives, as appropriate.
- Manage program for calibration and preventive maintenance of equipment/tools used in instrument production environment
- Ensure calibration and maintenance activities are completed on or before due date
- Collaborate with Global equipment controls process owners to ensure local program is aligned with company requirements
- Manage local implementation of any changes to program requirements (e.g. documentation and record updates, training)
- Develop and deliver instructor-led training to equipment owners and other stakeholders
- Assist Equipment Owners with onboarding of equipment
- Maintain program documentation (work instructions, forms, etc.)
- Identify and implement improvements to program requirements and practices
- Interface with service providers to coordinate onsite activities and inputs to/reporting from hosted software solution
- Notify responsible personnel/user of upcoming calibration and maintenance due dates;
- Once received back from service providers, verify calibration report is acceptable and review equipment records for completeness and accuracy
- Interface with Contract Manufacturers
- Represent equipment controls program in internal and external audits
- Management of records
- Initiate Out of Tolerance Report and ensure process is completed on time
- Create calibration and maintenance reports on a regular cadence
- Track and trend calibration and maintenance data
- Conduct periodic review to ensure accuracy of equipment status and records
- Review and approve change orders related to calibration and maintenance
Required Experience and Education:
- Bachelor’s or Associate’s degree in a scientific or technical field; e.g., electrical engineering, mechanical engineering, chemical engineering, biology, etc. or equivalent experience and/or certification
- 3-5 years of experience in medical device Quality Assurance or Manufacturing, applying quality regulations and standards (e.g., 21 CFR 820, ISO 13485)
- Excellent interpersonal, verbal, and written communication skills
- Excellent attention to detail, well organized and able to work both independently and in teams
- Knowledge of Good Documentation Practices/Good Manufacturing Practices;
- Must be able to identify and recommend effective solutions to problems and working individually and with others within and outside his/her function
- Familiar with the use of standard measurement tools such as calipers, micrometers, height gauges, thread gauges, and pin gauges etc.
- Ability to understand and interpret tolerances
- Direct experience working in in vitro diagnostic device manufacturing and/or Quality
- Proficient with MS Office Suite (Outlook, Excel, and Word)
- Experience working with Quality System Databases and ERP systems. (e.g., SAP, EtQ)
- Able to identify key issues and take initiative to drive toward continuous improvement.
- Can effectively and efficiently coordinate several tasks at the same time
- Knowledge of FDA and ISO requirements pertaining to calibrations and maintenance, and control and monitoring of Measuring Devices;
- Strong critical thinking and problem-solving skillsets
- Experience in investigation methodologies and root cause analysis techniques associated with product and process failures
- Quality Certification (e.g., ASQ CQE or CQA, ISO 13485 Auditor)
- Six Sigma Green Belt, Black Belt, or other Lean training