Scheduled Maintenance: sisystems.com will be Unavailable from Friday, Dec 9th @ 8:00 PM MST - Saturday, Dec 10th @ 8:30 AM MST for regularly scheduled maintenance.
Login | Register

Intermediate Quality Engineer to support and oversee Design and Development, Production and Process Controls and Post-Production surveillance activities, in accordance with the Quality System and applicable regulations in the Medical Device Industry

Job Type: Permanent
Positions to fill: 1
Start Date: Nov 21, 2022
Job End Date: Nov 21, 2022
Pay Rate: Salary: Negotiable
Job ID: 125119
Location: Vancouver, Victoria
Apply
Intermediate Quality Engineer to support and oversee Design and Development, Production and Process Controls and Post-Production surveillance activities, in accordance with the Quality System and applicable regulations in the Medical Device Industry
 
Must haves:
  • 2-3 years’ experience in medical device industry mandatory
  • Degree in Mechanical, Manufacturing or Biomedical Engineering
  • Design Quality Assurance/ Design for Manufacturability (DFMEA/ PFMEA).
  • Production and Process Controls.
  • Working knowledge of statistics.
  • Familiarity with sterilization methods.
 
Nice to have:
  • ASQ Certified Quality Engineer an asset.
  • Experience with any of the following is considered an asset: Medical Plastic Extrusion/Molding, Polymer Bonding, Balloon Manufacturing.
 
Responsibilities:
  • Identifies and resolves exceptions to work assignments
  • Follow-the-data best practices to identify appropriate actions.
  • Performs exploratory analyses across design and production (Design FMEA, Process FMEA).
  • Participates in Risk Management activities, knowledge of ISO 14971.
  • Participates in Customer Complaints investigation.
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Supports day-to-day manufacturing operations, including QC, to ensure continuity of compliant product.
  • Participates in validation activities.
  • Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • Participates in regulatory inspections and notified body audits, acting as an SME for areas of responsibility.