Quality Assurance Manager - Montréal, Canada - THORASYS Thoracic Medical Systems Inc.

Description

Come Join the THORASYS Team

THORASYS Thoracic Medical Systems Inc. is a young medical device company based in Montreal's MileEx neighbourhood.

We develop, manufacture and market advanced diagnostic medical devices incorporating novel approaches to pulmonary function testing that aid the diagnosis and monitoring of lung diseases such as Asthma and COPD.

We believe that better measurements of lung function in more patients improve patient care, prevent exacerbation and reduce health care spending.

We think that's important.

We use innovative technology to deliver novel tools for fast and easy pulmonary assessment that shape new perspectives on pulmonary function.

Our vision is to make point-of-care pulmonary function testing as easy as blood pressure measurement is today.


We are looking for a:

Quality Assurance Manager


1 Responsibilities:

• In this position, you are responsible for managing our ISO 13485 quality management system, quality assurance, regulatory affairs and for the management of regulatory filings for new products registrations.

1.2 Specific responsibilities include:

• Manage, maintain, improve, further develop and obtain certification for THORASYS' companywide quality management system (QMS) as required to ensure efficient operations and continuing compliance;
• Prepare and manage internal and external audits of our QMS;
• Train new and existing employees on the QMS procedures pertaining to their functions;
• Ensure that all THORASYS products and services are developed, manufactured, sold and supported in full compliance with all applicable medical device guidelines and directives, including, without limitation, ISO 13845, ISO 60601, etc.;
• Oversee the regulatory approval of our products in all target jurisdictions as defined by our corporate strategy;
• Perform corrective and preventive actions (CAPA), nonconformity (NC) analysis, manage the CAPA and NC logs;
• Maintain the Device Master Record and assist in maintaining the Design History Files and Design History Records;
• Review and maintain the Device History Record;
• Act as the management representative for quality which includes preparing statistics on key quality indicators of the QMS as an input to the management review process;
• Assist in writing and reviewing technical change orders as part of the design change control process;
• Conduct or directly manage the validation of our software tools and production processes; maintain the validation master plans;
• Conduct supplier audits and supplier qualification; and
• Assist the technical support group in root cause analysis and regulatory reportability assessment of complaints.

1.3 As for all THORASYS employees, your position may include a limited amount of administrative duties and travel.


2 Education required:

• Bachelor degree in engineering or technical degree combined with relevant experience.

3 Competence required:

• Indepth knowledge of medical device regulations is essential for this position;
• Good manufacturing practices, quality management systems and standards in the medical device field
• Good technical writing skills;
• Skills in work planning and problem resolution;
• Good spoken and written English and French language.

4 Experience required:

• 510 years in managing quality assurance and regulatory affairs in the field of medical devices.

5 Report:

• Unless otherwise specified by the COO, you report to the Vice President-Engineering of the company.
• As indicated in our quality manual, the RA/QA manager must notify the president and the CEO of the company for any major deviations from the quality system or for any incidents reported involving the use of a company product (reportable event).