Job Description

JOB SUMMARY

The Quality Process Analyst solves quality problems and is involved in quality improvement projects. This role can perform the document control processes, which includes making document changes, routing for review and approval, making documents effective, distribute documents and make notifications. In addition, the Quality Process Analyst can execute the training process, which includes routing training assignments, ensure training has been completed and filing training records. Also, the role will help level-load work by supporting and backing up Inspectors and Quality Engineers.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

• Follow all procedures and work instructions defined in the Quality System Manual
• Execute Document Change Requests
• Coordinate training
• Assist in executing calibration activities
• Assist in RMA process
• Perform Inspections
• Support all audit activities
• Perform other duties as assigned by manager or supervisor

EDUCATION & EXPERIENCE REQUIREMENT

• Must have proven attention to details and excellent organization skills
• Minimum of two-year degree or equivalent experience; ability to apply learned technology to Company products and processes
• Intermediate proficiency with Microsoft Word & Excel, Adobe Acrobat, LabelView, eQMS, Syspro
• Must possess excellent verbal and written communication skills in English, which includes the ability to read, write and speak to comprehend and execute internal procedures, drawings and Manufacturing Work Instructions (MWI's)

PREFERRED SKILLS & ABILITIES

• Medical device industry experience
• Medical Device regulation requirements knowledge, as applicable to responsibilities
• ASQ certification as a Quality Process Analyst

WORKING CONDITIONS & PHYSICAL DEMANDS

• Regularly sit at a computer workstation
• Must be able to fulfill all requirements for cleanroom access
• Ability to lift and move materials and product up to 55 lbs.

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