Quality Control Specialist
Description:
Job Description
PURPOSE OF JOB:
Support Route 92 Medical’s efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements such as FDA QSR, ISO 13485, and the EU MDR. Ensure all products meet all applicable internal and external requirements from product conception to market release.
MAJOR DUTIES AND RESPONSIBILITIES:
Primary Responsibilities
Receiving and inspection of components, subassemblies, and supplies.
Scheduling and/or performing equipment calibration and preventive maintenance.
Manufacturing inspections, sterilization preparation, and product labelling.
Processing of nonconforming materials / products.
Secondary Responsibilities:
Transferring to and from inventory locations.
General support for other QA functions as needed.
EDUCATION:
High School Graduate or Equivalent required.
Associate Degree in a Technical Field preferred.
EXPERIENCE:
Minimum of 3 years of work experience in the medical device industry.
ADDITIONAL SKILLS:
Basic skills with Microsoft Office Suite required.
Experience with eQMS Software preferred.
Experience with inspection tools such as calipers, gauges, preferred.
Working knowledge of 13485:2016 preferred.