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Manufacturing Engineer Jobs

Company

Novozen Healthcare LLC
Address Toronto, Ontario, Canada
Employment type CONTRACTOR
Salary
Category Medical Equipment Manufacturing,Pharmaceutical Manufacturing
Expires 2023-08-06
Posted at 9 months ago
Job Description
  • Performs other related duties as necessary.
  • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
  • Work on project teams with other internal departments, external vendors, and customers as required.
  • Troubleshooting equipment/processes that do not perform as intended during validation runs.
  • Recommend process/quality improvements as part of validation runs. Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
  • Generation and implementation of change controls and engineering notices (ECO).
  • Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
  • Provide statistical analysis of the date to support the reports.
  • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
  • Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
  • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
  • Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.