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Quality Assurance Engineer (medical Devices)

Sonoscope

This is a Contract position in Longueuil, QC posted November 17, 2020.

OBJECTIVES OF THE POSITION: SONOSCOPE is looking for an engineer who will play a key role in the development of the company, and who will be responsible for the harmonization of the technical documentation in accordance with the ISO 13485 environment and will ensure the smooth implementation of the regulatory strategy.

The incumbent will perform the following functions under the supervision of the Chief Engineer: RESPONSABILITIES : Product Development
– Take part in the development of medical devices and design reviews.

– Review the required technical specifications taking into account the applicable standards.

– Take part in the assessment of risks associated with products and processes.

Quality Assurance & Regulation
– Oversight of the Quality Management System (QMS) and its activities (GCMP, CAPA, V&V)
– Prepare documentation in support of design history files and regulatory submissions
– DHF and DMR maintenance
– Assist in the development of the regulatory strategy.

– Definition and revision of operational procedures (SOPs) Protocols and tests
– Develop and execute product testing methods in accordance with applicable standards.

– Write and execute design verification and validation protocols in accordance with applicable standards.

– Supervise and perform testing and inspection of prototypes.

Other Responsibilities
– Collaborate with the company’s partners and subcontractors.

– Provide training to employees on QMS and regulations.

– Performs additional duties as assigned by the Chief Engineer or Chief Technology Officer.

The ideal candidate will meet the following requirements: REQUIREMENTS:
– Bachelor’s degree in Biomedical Engineering
– 3 to 5 years’ experience in the medical technology industry
– Experience in a highly regulated environment and applied knowledge of standards governing medical devices (ISO 13485, ISO 14971, IEC 60601-1 and 60601-1-2, 21 CFR regulation, etc.)
– Experience in process verification and validation, including statistical justification
– Proficiency in the AGILE/SCRUM method
– Fluency in English (spoken and written) ASSETS:
– Experience in the design of complex medical devices for the American, European or Asian markets
– Knowledge of IEC 62304
– Knowledge of TIR45 :2012
– Experience with Class IV medical devices (Health Canada)
– Knowledge of ultrasound equipment
– Previous involvement in a clinical trial process
– Member of the OIQ PROFESSIONAL QUALITIES:
– Rigor, autonomy, initiative, leadership and curiosity
– Creativity in problem-solving WHY JOIN SONOSCOPE:
– To join a team led by international leaders in emergency and resuscitation medicine
– For the opportunities to grow professionally and personally
– To join a company powered by Centech, one of the most successful business incubators in North America
– For a competitive remuneration
– For the control and autonomy allowed in the execution of tasks
– For the freedom of a flexible schedule
– For the proximity of our offices to downtown Montreal and easy access to public transportation HOW TO APPLY : Send your resume before December 15th, 2020.