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Form of workJob Description
Job Description: Major Accountabilities:
The Operations Quality Engineer will lead activities involving assigned routine product inspections, product impact assessments for events, product quarantine activities, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliance with 21CFR820, ISO, and other regulatory requirements as well as internal requirements.
Essential Functions
Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to QA Ops Management and QA team.
Actively participates in Production Triage team as the lead Quality member by providing direction and support on the non-conformance process, product impact assessment, root cause analysis, and product quarantine as non-conformances arise. Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area.
Performs real time Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions/activities. Ensures all required documentation is accounted for and ensures that the documentation is an accurate representation of activities on the production floor.
Initiates and leads QA Ops process improvements from start to implementation including creating/revising procedures using the Change Control process.
Interact in a team environment with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.
Lead and/or support other duties as assigned.
Bachelor s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
Strong computer skills (including Excel)
Demonstrated written and verbal communication skills
Comments for Suppliers: Looking for two Contractors for the following Shifts:
Mon-Wed and every Other Thurs, 4PM-4AM
Thur-Sun and every other Wed, 4AM-4PM
The Operations Quality Engineer will lead activities involving assigned routine product inspections, product impact assessments for events, product quarantine activities, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliance with 21CFR820, ISO, and other regulatory requirements as well as internal requirements.
Essential Functions
Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to QA Ops Management and QA team.
Actively participates in Production Triage team as the lead Quality member by providing direction and support on the non-conformance process, product impact assessment, root cause analysis, and product quarantine as non-conformances arise. Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area.
Performs real time Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions/activities. Ensures all required documentation is accounted for and ensures that the documentation is an accurate representation of activities on the production floor.
Initiates and leads QA Ops process improvements from start to implementation including creating/revising procedures using the Change Control process.
Interact in a team environment with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.
Lead and/or support other duties as assigned.
Bachelor s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard;
Strong computer skills (including Excel)
Demonstrated written and verbal communication skills
Comments for Suppliers: Looking for two Contractors for the following Shifts:
Mon-Wed and every Other Thurs, 4PM-4AM
Thur-Sun and every other Wed, 4AM-4PM
