Job Description

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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