Overview
We are seeking a dedicated and experienced Quality Control Manager to oversee our quality assurance processes and ensure compliance with industry standards. The ideal candidate will play a crucial role in maintaining the integrity of our products by implementing effective quality management systems. This position requires a strong understanding of ISO 9001 and have the ability to prepare for ISO 13485 Medical certification.
Responsibilities
- ISO Management
- Review / update ISO procedures / work instructions as required
- Ensure compliance throughout the organization
- Manage internal audits
- Conduct periodic management reviews
- Coordinate all ISO audits / scheduling /etc
- Prepare for ISO 13485 Medical Certification
- Metrics Board
- Maintain/ create/ distribute metrics reports-present at PMR meetings
- Each manager is responsible for their own metrics generation
- Perform monthly DPPM calculations, track results for trends
- Improve scrap rates / reduce errors
- DMR/RMA’s via MieTrak (ERP system currently being used)
- Issue RMA’s via MieTrak
- Ensure internal rejects are tracked via DMR’s in MieTrak
- MRB
- Present list of open DMR/RMA at weekly production meetings
- CAR/SCAR
- Log CAR’s in CA log
- Collect internal responses and complete CAR documents for customer submission
- Calibration
- Internal-maintain calibration and registration of all company and employee owned devices (within our capabilities)
- External-contact and coordinate outside suppliers to calibrate items outside our capabilities (Fabrvision, surface plates, scales)
- Inspect incoming purchased products/services (paint, plating, machining, etc.) per receiving inspection sample plan
- Set up / first piece inspections
- Department leads should be able to verify department setups. QA personnel should support the activity in event of multiple set ups to alleviate any downtime/ backlogs
- Train leads in each department
- In process inspections
- Train operators to verify their own work. QA personnel should review/ audit process outputs throughout the day as a secondary verification
- PPAP/FAIR
- Balloon prints using Discus software
- Create the master Excel file to capture dimensional date
- Complete all required documents within the workbook to meet customer expectations (control plans, process flows, etc.)
- Training and Development
- Operator-in shop classes (print reading /understand necessities / make sure prints are focused on areas)
- Q.A. Personnel
We invite qualified candidates who are passionate about maintaining high-quality standards in their work environment to apply for this pivotal role in our organization.
