Quality Engineer

Our client is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Currently, we are looking for a Quality Engineer to join the team in their Scarborough location. 

Must have the Medical Device or Pharma background. 
Salary: $65K+ (Temp to Perm)
Working location: Scarborough

Responsibilities:

• Assist or lead complaint handling activities (e.g., investigations).
• Assist or lead in the identification and implementation of CAPA.
• Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).
• Assist with and implement service and repair quality processes.
• Facilitate the execution of Risk Management activities.
• Support new product development and production (e.g., Change Control implementation activities).
• Provides support necessary for supplier controls, including but not limited to, supplier audits.
• Support validation activities for new and existing products, process and equipment and identify statistically based sampling plans for inspections and validations.
• Aid in the implementation SPC control system with Manufacturing and Quality Control.
• Establish and maintain Quality Management System procedures related to areas of responsibilities.
• Ensure compliance with cGMP, QSR, ISO13485, MDD/EU MDR, and other applicable regulations/ standards.
• Participate in FDA, Health Canada inspections, ISO Certification and surveillance and customer audits.
• Identify and implement opportunities for continuous improvement.
• Collection and reporting of metrics and data as required.
• Performs other Quality Management System related duties as required.

Qualifications:

• BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 3-5 years of working experience in Quality Assurance/Control.
• Minimum of two years’ experience in a regulated industry, preferably Medical Device Industry
• Experience with CAPA processes (e.g., complaints, nonconforming product).
• Exposure to medical device regulations (including FDA QSRs, ISO13485).
• Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
• Knowledge of statistical sampling and analysis.
• Ability to communicate effectively (both written and oral).
• Familiar with the MS Office Suite, including Microsoft Visio and Project.
• Must be able to observe company policies and safety procedures at all times.
• Demonstrated ability to work cross-functionally in a team environment.

How to Apply:

Please send your resume to careers@gc-employment.com with the subject "Quality Engineer - Scarborough".