Specialist/Project Manager, quality assurance

Brief description of the position :

In order to meet the needs of our customers in the Medical Devices sectors, FOP CONSULTANTS is looking for quality assurance consultants motivated to carry out mandates. The main missions would be to review and approve quality documents (SOP, protocols, etc.), collaborate on customer complaints, write non-conformity reports, investigation, change control, CAPA, present performance indicators and perform all quality assurance tasks related to medical devices.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage projects related to quality assurance procedures and documentation;
• Revise and write quality documents (SOP, protocols, instructions, etc.);
• Document customer complaints and ensure that investigations are opened to resolve them;
• Provide KPI data to assess business performance;
• Act as a support to respond to requests on the quality of medical products;
• Carry out regulatory monitoring to learn about GMPs related to medical devices;
• Collaborate with teams from different departments to resolve quality issues related to deviations, change control, CAPA and investigations;
• Participate in any project to improve the quality assurance system;
•  Participate in weekly or monthly meetings on regulatory files;
• Provide solutions to problems encountered and perform all tasks relevant to the mandate.

Qualifications :

• Bachelor's or Master's degree in science (medical technology, chemistry, biochemistry, etc.) engineering (biomedical; biomechanics, mechanics, physics) or any other related discipline;
•  1 (one) to 10 (ten) years of experience in the medical device, hospital or related industry;
• Project management (an asset);
• Experience in quality assurance in the field of medical devices, pharmaceuticals;
• Knowledge of ISO 13485 standards;
• Knowledge of FDA, Health Canada regulations;
• Knowledge of classes I, IIa, IIb and III of medical devices;
• Excellent command of MS Office suite;
• Good communication and writing skills in French and English;
• Mobility (an asset).

Personal skills :

• Leadership;
• Rigor et discipline;
• (Organize), able to manage several projects;
• Analytical and critical mindset;
• Perseverance;
• Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

• Competitive wages;
• Group insurance;
• Professional insurance;
• Remote work, according to the customer needs;
• Vacations: 3 weeks;
• Paid sick leave: 3 days;
• Monthly transportation fees;
• Career advancement opportunity;
• Continuing education.