Quality Control Manager

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 reportspresent at PMR meetings

each manager is responsible for their own metrics generation

perform monthly DPPM calculations track results for trends

Lower s / mistakes

DMR / RMAs via Mietrak ERP system currently being used)

issue RMAs via Mietrak

ensure internal rejects are tracked via DMRs in Mietrak

present list of open DMR / RMA at weekly production meetings

CAR / SCAR

log CARs in CA log

collect internal responses and complete CAR documents for customer submission

Calibration

internalCalibrate and log all company and employees owned devices (within our capabilities)

externalcontact 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

operatorin shop classes print reading / understand necessities / make sure prints are focused on areas)

QA Personnel

Thanks

Vizonere LLC

Key Skills

Laboratory Experience,Quality Assurance,Construction Experience,FDA Regulations,ISO 9001,Assays,Quality Systems,Quality Control,Quality Management,cGMP,QA / QC,HACCP

Employment Type : Full Time

Experience : years

Vacancy : 1