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Quality Manager MA Open (J#25790)
Education: Bachelors Degree

FUNCTION

Growing plastics manufacturing company in Eastern Massachusetts is searching for a Quality Manager.

Essential Functions/Responsibilities:

Assure that company maintains regulatory compliance with ISO 9001, ISO 13485 and AIB Food contact manufacturing guidelines

Routine internal auditing

Drive corrective and preventive action assignments to closure

Establish and maintain outsource relationships (regulatory agencies, pest control, quality consultants, measurement resources, etc.

Coordinate management review process

Provide timely response to customer requests

Provide accurate and timely responses to complaints & corrective actions

Work with customers to coordinate, arrange for and respond to customer audits

Assurance quality of product through incoming, in-process and final inspection

Oversee quality assurance department

Provide approvals for final device history records for products

Collaborate with internal and external customers to define and document quality assurance requirements for new products

Develop and document measurement methods & sampling plans for new quality assurance processes

Coordinate and control all documentation

Maintain document control for all electronic and hard copy documentation to current revisions.

Drive review and completion of engineering change notices

Assure calibration of all measurement devices are up to date

Monitor all devices

Arrange for calibration of devices in the most efficient and cost effective manner

Lead material review board (MRB) to review and provide disposition for non-conforming material

Requirements:

5+ years in Quality Management role; 10 years in quality related functions

Injection molded product experience preferred

Experience managing ISO 9001 & 13485 quality systems

Experience with food contact regulation (AIB or equivalent) preferred

Understanding of GD&T; knowledge of inspection techniques and procedures

Exceptional overall organizational and project management skills

Effective internal and external communication skills

Must work well in a team environment. Experience managing a group preferred

Experience using IQMS and Minitab a plus
 
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