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Quality Assurance Manager in Menomonee Falls, WI at PointOne Recruiting Solutions

Date Posted: 5/10/2019

Job Snapshot

Job Description

Category: Manufacturing & EngineeringJob Location: Menomonee Falls, WI

The Quality Assurance Manager is a senior level position responsible for establishing and reviewing process controls, emphasizing customer satisfaction, continuous improvement, and waste reduction.  Measurement systems and inspection techniques are to be developed and maintained to advance department goals and objectives in support of plant goals and objectives as monitored and reported through Key Performance Indicators (KPI’s).  

The Quality Assurance Manager reports directly to the Plant Manager, with a dotted line report to the Vice President of Quality and Continuous Improvement to plan and direct all quality related functions in the plant to drive a behavioral based quality mindset throughout the facility.    


Learn and master all necessary areas of the quality system and hold your team accountable to procedures
Follow and hold team accountable to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Direct activities and resources to maintain third party registration for the manufacturing and assembly of single and multi-shot plastic parts per IATF-16949 standards, ISO 9001:2015 and ISO 13485:2016 standards, which shall include being the quality management representative on the management review team and overseeing document and data control
Manage customer audits and reviews/analyzes data and documentation
Oversee all work instruction standards and procedures to identify deviations from quality standards
Proactively look for opportunities for improvement, put action plans in place, and develop new processes/procedures


Bachelor’s Degree in Engineering or related field

10+ years of Quality Leadership experience

Proven operational excellence experience in a large plastic injection molding environment or medical device manufacturing environment

Working knowledge of part layout, SPC, engineering specifications, ISO 13485 and class 8 clean room operations

Demonstrated experience in problem solving (5Y, 8D, CAPA)

Experience interfacing with customers

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