Position Title: Engineering Technician
Reports to: Director of Operations
Administer and Maintain regulatory compliance records in support of our critical business process including; Change Management, Engineering Standards, Calibration, Maintenance, Management Review, Internal Quality Audits, Process Validation, Inspection and Testing, Nonconforming Material, and others.
Support execution of our Operations and Quality processes by providing expertise in our ERP system.
- Support customer and regulatory audits by providing evidence of compliance and by gathering and presenting quality records, as required
- Support Manufacturing and Quality Engineering in the release, revision, and obsolescence of production documentation and engineering standards
- Assist with writing documentation, including processing red-line documents, as needed to support engineering and operations
- Maintain all change logs and master document indexes
- Perform process audits
- Update and publish Plant and Departmental Metrics
- Support customer qualification activities, including MVP, IQ, OQ, and PQ
- Execute First Article Inspection reports, including inspection and testing
- Providing administrative support for the Management Review process by gathering and preparing meeting materials
- Other duties as assigned
- Basic knowledge and understanding of ISO 9001:2015, ISO 13485:2016, and FDA GMP requirements
- Intermediate/Advanced MS Office proficiency (Word, Excel, Access)
- Strong organizational skills with proven experience and competency in multi-tasking
- 2 year technical or business degree, or equivalent experience
- MicroVu experience preferred
All Preco, Inc. employees are empowered to stop production and notify their supervisor/manager if an unsafe act or product quality concern is occurring. Also, each member of the Preco – Hudson team is responsible for identifying continuous improvement opportunities and participating in problem solving teams as necessary.
Send resume to: firstname.lastname@example.org
This position is located in Hudson, WI