Quality Engineer at Engineering Resource Group
East Hanover, NJ
About the Job
Description
Contract position for a Quality Engineer for medical device manufacturing, performing inspections and audits.
Participate on cross functional product teams for the development of new and modified orthopedic systems.
Specify, develop, and validate quality control methodology, quality planning, and test equipment at the supplier's process.
Provide quality control technical expertise and leadership to operations and development with respect to design requirements, dimensioning and inspection techniques, and capabilities
Assist with the development of the design history file and all included records.
Assist with project milestones such as design reviews, phase reviews, risk analysis, drawing reviews, etc.
Perform periodic documented examination and verification of activities, records, and processes of any given quality system to determine the effectiveness and dependability of such system.
Evaluate internal processes and results comply with the requirements of procedures, quality, and regulatory requirements.
Develop audit plans and schedules.
Participate in quality audits, identify gaps and issues where a department is meeting requirements, as well as identify opportunities for improvement.
Develop audit reports, assist with follow up audits as required.
Requirements
BS Engineering
Minimum 5 years experience with medical device manufacturing and quality assurance.
Knowledge of FDA Quality Systems Regulations and International ISO quality systems standard.
Understanding and interpretation of engineering drawings and specifications, GD&T tolerance schemes.
Comprehend quality planning tools such as first article inspections, process failure modes and effects analysis, measurement system analysis, inspection planning.
Understanding of manufacturing processes.
Understanding of FDA Quality System's Regulations and ISO 13485 standard.
Understanding of the regulatory design control process.
Aptitude to learn new processes and software applications.
Contact
Click Apply to job, or call me, Bill Zukowsky, at
128
Job #: 21792-BZ1
#ERGx
To view all of our job openings, visit:
careers.terkotech.com
#ERGX #TTX
Contract position for a Quality Engineer for medical device manufacturing, performing inspections and audits.
Participate on cross functional product teams for the development of new and modified orthopedic systems.
Specify, develop, and validate quality control methodology, quality planning, and test equipment at the supplier's process.
Provide quality control technical expertise and leadership to operations and development with respect to design requirements, dimensioning and inspection techniques, and capabilities
Assist with the development of the design history file and all included records.
Assist with project milestones such as design reviews, phase reviews, risk analysis, drawing reviews, etc.
Perform periodic documented examination and verification of activities, records, and processes of any given quality system to determine the effectiveness and dependability of such system.
Evaluate internal processes and results comply with the requirements of procedures, quality, and regulatory requirements.
Develop audit plans and schedules.
Participate in quality audits, identify gaps and issues where a department is meeting requirements, as well as identify opportunities for improvement.
Develop audit reports, assist with follow up audits as required.
Requirements
BS Engineering
Minimum 5 years experience with medical device manufacturing and quality assurance.
Knowledge of FDA Quality Systems Regulations and International ISO quality systems standard.
Understanding and interpretation of engineering drawings and specifications, GD&T tolerance schemes.
Comprehend quality planning tools such as first article inspections, process failure modes and effects analysis, measurement system analysis, inspection planning.
Understanding of manufacturing processes.
Understanding of FDA Quality System's Regulations and ISO 13485 standard.
Understanding of the regulatory design control process.
Aptitude to learn new processes and software applications.
Contact
Click Apply to job, or call me, Bill Zukowsky, at
(973) 490-7000
ext128
Job #: 21792-BZ1
#ERGx
To view all of our job openings, visit:
careers.terkotech.com
#ERGX #TTX
