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in Berlin, CT
Quality - Senior Quality Engineer
Hours | Full-time, Part-time |
---|---|
Location | Berlin, Connecticut |
About this job
Quality - Senior Quality Engineer
We are seeking a highly skilled, highly motivated experienced Senior Quality Engineer. Candidates should have 5 plus years of experience as a Quality Engineering in a high-volume manufacturing environment with focus on molded medical components and assemblies.
This individual will interact with all levels of the organization. Primary responsibilities include the role of QA Lead on new projects which include Failure Mode and Effects Analysis, Process Control Development, Data/Measurement System Analysis and Problem Solving. In addition, this role maintains responsibility for sustaining operational activities.
Essential Duties and Responsibilities:
1. Manage QA responsible functions for new process development projects.
2. Facilitate the cross functional development of Process Failure Mode and Effects Analysis/ Product Control Plans with documentation into the ERP system as required.
3. Measurement method identification including the use of statistical techniques for process control.
4. Measurement Systems Analysis.
5. Analysis of data.
6. Develop inspection instructions and associated documentation to ensure consistent and accurate inspection of products.
7. Champion root cause investigations and facilitate the completion of CAPA's.
8. Work with suppliers on quality related issues of products/services.
9. Support the quality inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
10. Handle special projects assigned by the Director of Quality.
Job Requirements:
Minimum
1. 5 years' experience in plastics injection molding
2. Good command of ANSI Y14.5 Geometric Dimensioning and Tolerance interpretation with practical application for functional gaging.
3. Working knowledge in one of the following: ISO Quality Management Systems with preference for ISO13485
4. Must be able to interpret dimensional/mechanical test results and be a clear and effective communicator of those to Manufacturing/Engineering personnel.
5. Proficiency in Minitab with working knowledge of Microsoft Office Suite
Preferred
1. Training in AIAG disciplines of APQP, MSA, FMEA, SPC, and PPAP
- Pay Type Salary
- Berlin, CT, USA