Quality Assurance Regulatory Affairs Coordinator Jobs in Quebec

Maintain all Quality Management meeting documentation.

Maintain and issue training requirements to company.

Maintain working knowledge of ISO 13485 and ISO 14971.

Maintain in depth knowledge of regulatory guidance documents.

Experience in documentation for Class II/III or IV medical devices, experience with 510(k) or De Novo Submissions a plus.

Experience with ISO 13485 or ISO 9001, experience with ISO 14971 a plus.

Keep welding procedures up to date with certification requirements;

Participate and support the activities of the Health, Safety and Environment Management System.

Ensure the application and maintenance of ISO certification in collaboration with the various teams;

Support project managers and foremen in the execution of projects to ensure work compliance;

Plan, prepare and carry out, in collaboration with the project manager – quality, external inspections carried out by Transport Canada;

Minimum of five (5) years of experience in a similar role;

Excellent common sense, decision-making abilities, interpersonal and analytical skills

Support development and implementation of processes using advanced knowledge of industry standards

2 years of experience in Garment Industries

Excellent written and verbal French and English skills

Strong knowledge of garment construction and patternmaking

Audit Finished Goods at end of line and report issues to Production