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Skills
Auditingunmatched
Biologyunmatched
Calibrationunmatched
Chemical Engineeringunmatched
Chemistryunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Equipment Maintenance/Repairunmatched
Equipment Validationunmatched
FDA (Food and Drug Administration)unmatched
Facilities Engineeringunmatched
Failure Analysisunmatched
Federal Laws and Regulationsunmatched
Healthcareunmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Medical Equipmentunmatched
Messaging Middlewareunmatched
Metrologyunmatched
Microsoft Excelunmatched
Microsoft Visiounmatched
Microsoft Windows Operating Systemunmatched
Microsoft Wordunmatched
OSHAunmatched
Office Equipmentunmatched
Organizational Skillsunmatched
Preventative Maintenanceunmatched
Process Engineeringunmatched
Quality Metricsunmatched
Record Keepingunmatched
Regulationsunmatched
Root Cause Analysisunmatched
Safety Processunmatched
Standard Operating Procedures (SOP)unmatched
State Laws and Regulationsunmatched
System Validationunmatched
Wound Careunmatched
Description
At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading surgical & advanced wound care products combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.
We are excited to add a Metrology Technician to our Quality team! The position will pay between $56,000 - $70,000 based on previous relevant experience and educational credentials. This is a full-time role working at our Marietta facility.
POSITION SUMMARY:
The Metrology Technician performs calibration and validation of equipment and systems. Maintains equipment records and calibration schedules in the electronic management system.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Add new equipment to the electronic management system (MQ1)
Maintain all equipment records and calibration/PM schedule in electronic management system
Assist Facilities or Process Engineering personnel with equipment technical or performance issues; working closely with Operations personnel to resolve daily equipment-relates issues.
Perform routine audits of the preventive maintenance and calibration program, including ensuring accurate labeling of all equipment
Coordinate and interact with equipment manufacturers, vendors, contractors and/or consultants on equipment maintenance and trouble-shooting tasks.
Perform independent calibration of equipment and manage day to day calibration schedule
Ensure that all work is performed in accordance with SOPs, cGMPs, safety procedures, quality standards, OSHA standards, other regulatory agency standards, and good maintenance practices.
Assist in root cause failure analyses, investigations and CA/PA's as required.
EDUCATION/EXPERIENCE:
Associate's Degree in an Engineering (Chemical, Mechanical, etc.) or Science related field (Biology, Chemistry, etc.) and two (2) years of relevant work experience working in the medical device field or in a Metrology role within an FDA regulated cGMP environment; or a combination of relevant education and experience.
Knowledge of the following: AATB, FDA, ISO and other state/federal regulations
Strong computer skills, including proficiency at MS Word, MS Excel, MS Visio, and Windows-based operating systems
SKILLS/COMPETENCIES:
Excellent organization and communication skills with attention to detail
Ability to work independently
WORK ENVIRONMENT/EXPECTED BUSINESS TRAVEL:
The work is typically performed in a normal office environment. Role routinely uses standard office equipment.