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 certi
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
Lower scrap / mistakes
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-Calibrate and log all company and employees owned devices (within our capabilities)
-external-contact and coordinate outside suppliers to calibrate items outside our capabilities (Fabrvision, surface plates, scales)
Incoming Inspection
-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
-ballon prints using Discuss 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)
-QA Personnel
Thanks
Vizonere LLC
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