JOB DESCRIPTION
Quality technician is responsible for the inspection and testing of manufacturing processes and products to ensure the product quality. The process quality technician will work with a variety of inspection and test equipment and methods, processes, and products, ensuring proper procedures are being followed and documented to maintain product quality and records traceability. The process quality technician will also assist to ensure nonconforming product is appropriately identified, contained, and removed from the production flow until such product can be dispositioned through non-conformance process.
Job Responsibilities:(Primary Duties, Roles, and/or Authorities)
- Monitor production processing via random QA audits
- Support/perform necessary quality inspections using proper equipment and techniques
- Conduct statistical analysis on select processes and report findings
- Help with problem solving – root cause analysis – corrective actions
- Assist with accurate documentation of quality inspection results
- Support production monitoring raw materials comply to required specifications
- Monitor outgoing products are in compliance with required specifications
- Ensure production personnel are following proper procedures for ongoing production checks
- Assist with training and instruction for production operators in QA measuring procedures
- Development and maintenance of quality procedures and work instructions
- Audit and maintenance of compliance to required quality management system standards
- Provide support management with detailed quality reports as required – daily, weekly, monthly, etc.
- Other duties as required by quality management
Education and Experience:
- Bachelor's degree in engineering, life sciences, or a related technical discipline is required .
- Minimum 3–5 years of lead, technician or inspector engineering experience in the medical device or pharmaceutical industry.
Knowledge and Skills:
- Ability to work with little supervision
- Experience enforcing SWI / SOPs and product specifications
- GMP / GDP knowledge
- Knowledge in Excel
- Strong mathematics skills
- Knowledge on Quality criteria and standard regulations
- Experience with measuring equipment