Quality Engineer III - Integrated Resources, Inc
Mansfield, MA 02048
About the Job
SUMMARY DESCRIPTION
The Sr. Quality Engineer II will utilize Quality Engineering tools and practices for the effective
and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall
Quality and Business vision. The individual will utilize appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.
This person will support processes in base business and supervise, lead and mentor other Engineers and Technicians.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to: EUMDR Class II & III Compliance Projects
Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required
remediation activities.
Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Conduct benchmarking to develop more effective methods for improving quality.
Approve IQ, OQ, PQ, TMV or Software Validations.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
DESIRED MINIMUM QUALIFICATIONS
Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master s degree with 5+ years of experience, Doctoral degree with 3+ years of experience
This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with a proven track record of implementing appropriate risk mitigation.
The Sr. Quality Engineer II will utilize Quality Engineering tools and practices for the effective
and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall
Quality and Business vision. The individual will utilize appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.
This person will support processes in base business and supervise, lead and mentor other Engineers and Technicians.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to: EUMDR Class II & III Compliance Projects
Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required
remediation activities.
Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation.
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
Conduct benchmarking to develop more effective methods for improving quality.
Approve IQ, OQ, PQ, TMV or Software Validations.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
DESIRED MINIMUM QUALIFICATIONS
Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master s degree with 5+ years of experience, Doctoral degree with 3+ years of experience
This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
Experience with a proven track record of implementing appropriate risk mitigation.
Source : Integrated Resources, Inc