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Viant, Inc. Grand Rapids, United StatesThe Quality Engineer actsas the primary contact for operations on all quality issues. This individual supports the launch and sustaining production of Class I and II Medical Devices. They assure Value Stream activities remain in compliance with FDA/ ISO regulations/ standards/ gu ...
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Manufacturing Quality Engineer
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Quality Engineer - Grand Rapids, United States - Plasan North America, Inc.
Description
Job DescriptionJob Description
POSITION REQUIREMENTS
(Required Tasks)
Generates APQP forms to ensure an effective Product Launch/Change regarding Quality and Customer Specific Requirements (CSR)
Ensures that non-conforming product is properly identified and quarantined for their products
Follow and maintain Non-conforming Product process and procedures, via Non-conforming Product (NCP)
Coordinates the processing of customer Returns, with a goal to exceed Customer expectation in turnaround and analysis reporting
Collects, analyze and chart internal process results, reject data and customer satisfaction data towards continuous improvement
Initiation of Internal, External Customer, or Sub Contractor
Corrective/Preventive
actions to eliminate or prevent non-conformances
Recommends changes and improvements to internal documents, work instructions, checklists within QA/QC or operations to provide efficient and effective processes
Schedule and hold meetings with external and internal customer quality contacts to improve Customer Satisfaction and drive continuous improvement
Perform in-process and final inspection on finished product at manufacturing facility and sub-contractors
Possesses thorough working knowledge of both mechanical instruments (micrometers, dial calipers) and electronic instruments used in the composites industry
Able to use and understand QMS procedures, product specifications, product drawings and all necessary information to perform inspections on manufactured and sub-contracted parts
Ensures ERP or product tracking system has been updated with product and quality related information
Assists with quality management system activities as directed
Follow all safety rules and procedures
All other duties as assigned
SKILL SET
(Required Skills)
Bachelor's Degree in Engineering or equivalent manufacturing experience
Minimum of 3 years' experience in the Quality field
ASQ CQA/CQE Certification desired
PHYSICAL DEMANDS AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Works at a desk and a computer screen for extended periods of time.Employee must be able to manually enter data to the computer system and understand the screen and images that appear.
Frequent lifting up to 35 pounds. Occasional lifting and pushing up to 80 pounds. Use of hands to hold, lift and handle materials. Occasional bending, squatting, and stooping.Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
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