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

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.