Quality Manager

Responsibilities:

·       Conduct N95 mask sampling plan collection from the production line(s) and operate laboratory test equipment (ATI, TSI and other instruments) in the Quality Lab.

·       Employee is expected to follow all safety regulations & wear PPE as required

·       Follow established procedures for the inspection, testing and acceptance of components/materials per Approved Supplier List (ASL) used in the manufacture of medical devices.

·       Perform review of Device History Records (DHR) and other documentation for release of finished goods.

·       Asses nonconforming materials and determine Root Cause Analysis & appropriate disposition.

·       Assist in writing, reviewing and updating Quality documents.

·       Monitor critical equipment and instrumentation to ensure proper operation and calibration.

·       Assist with Developing and implementing Safety systems and SOP’s.

·       Cooperates and supports all department supervisors and managers

·       Reports to the GM of Operations/Director of Quality

Education and Experience:

Education:

·      High School, Trade School or equivalent Work Training/Experience

 

Experience:

·      4+ years Quality Control Management in a production/manufacturing environment

·      Familiar with basic measuring and QA/QC tools & methods

·      Knowledge of IQ/OQ/PQ protocols and Continuous Improvement techniques

·      2+ years QC experience in Receiving Inspection is preferred

·      Familiarity with ISO9001 QMS essential and NIOSH knowledge a plus

·      Willingness to perform/assist in routine maintenance and small repairs

Good Mechanical and Electrical skills are a plus

Skills Required/Desired:

 Required:

·       Strong attention to details and follows Processes and Procedures

·      Excellent verbal and written communication skills in English. Spanish is a plus

·      Familiar with basic hand tools, power tools, measuring tools, etc.

·      Good math and problem solving skills are essential

·      Strong communication skills both verbal and written

·      Mechanical aptitude required

·      Previous experience in automated production machine operation

·      Ability to read and follow instructions & machine blueprints/drawings

·      Working knowledge of measurement instruments

·      Microsoft Office software skills required

Desired:

·      Authorized to work in U.S. with ability to pass a D.O.D. background check

·      Must have valid Driver’s License& Reliable Transportation

·      Must be able to pass background check and drug screen

·      Highly Motivated Self Starter with excellent work attendance

·      Must be a quick learner and able to react quickly and in a fast-paced environment

·      Excellent Team Leader and Motivator

·      Customer Service/Quality Driven

·       Team player and good on time work performance

 

Physical Demands:

·      Ability to stand and reach with hands and arms to operate and maintain equipment

·      Ability to walk sit, climb or balance; stoop, kneel, crouch, or crawl

·       Ability to regularly lift and/or move up to 25 pounds

Exempt

High School Diploma

None