Quality Assurance Manager

3 weeks ago

Montréal, Canada THORASYS Thoracic Medical Systems Inc. Full time

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’ company-wide 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**:

- In-depth 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**:

- 5-10 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).

  • Food Quality Assurance Auditor

    1 month ago

    Montréal, Canada Medina Quality Full time

    **Do you love to travel?** **Are you passionate about food safety and cross-cultural work?** **Do you have a strong belief in corporate social responsibility, diversity, and collaboration?** **If yes, Medina Quality is seeking charismatic, observant, self-disciplined and articulate applicants to join its audit team. Half the time you will be travelling...

  • Food Quality Assurance Auditor

    2 months ago

    Montréal, Canada Medina Quality Full time

    **Do you love to travel?** **Are you passionate about food safety and cross-cultural work?** **Do you have a strong belief in corporate social responsibility, diversity, and collaboration?** **If yes, Medina Quality is seeking charismatic, observant, self-disciplined and articulate applicants to join its audit team. Half the time you will be travelling...

  • Food Auditor

    2 weeks ago

    Montréal, Canada Medina Quality Full time

    **Seeking Position**: Food Auditor / Quality Assurance (1/2 Remote) **Do you love to travel?** **Are you passionate about food safety and cross-cultural work?** **Do you have a strong belief in corporate social responsibility, diversity, and collaboration?** **If yes, Medina Quality is seeking charismatic, observant, self-disciplined and articulate...

  • Manager, Quality Assurance

    4 weeks ago

    Montréal, Canada Alimentiv Full time

    A leadership role with Quality Assurance responsible for the delivery of Alimentiv’s global quality assurance services, overseeing, collaborating and driving quality compliance in the delivery of Alimentiv services. This role is responsible for meeting the operational responsibilities and objectives and includes staff performance management, departmental...

  • Bilingual Manager, Quality Assurance

    4 days ago

    Montréal, Canada First National Financial Full time

    Working together to be our best! First National is Canada’s largest non-bank lender, originating and servicing both commercial and residential mortgages since 1988. Over the past thirty years, we have been committed to hiring the best and brightest with over 1,000 proud team members. Through cooperation, ongoing coaching, development opportunities and a...

  • Quality Assurance Manager

    2 weeks ago

    montréal, Canada Brunel Full time

    Introduction We are seeking a proactive and experienced Quality Assurance Manager who is proficient in French and English to oversee and enhance our Client's food safety and quality systems. The ideal candidate will take ownership of maintaining the HACCP program and GFSI certification (BRC audit)

  • Quality Assurance Analyst

    1 month ago

    Montréal, Canada Onyx Technologies Full time

    Onyx Technologies is a leader in the CRM software market for the real estate industry. We are looking for a committed individual who will help us grow and consolidate our position in the international real estate software market. You have great ideas, your work ethic is remarkable, you have experience as a quality assurance analyst, and you are known for...

  • Quality Assurance Manager

    3 weeks ago

    Montréal, Canada Brunel Full time

    Introduction We are seeking a proactive and experienced Quality Assurance Manager who is proficient in French and English to oversee and enhance our Client's food safety and quality systems. The ideal candidate will take ownership of maintaining the HACCP program and GFSI certification (BRC audit), ensuring all products meet regulatory standards and customer...

  • Quality Assurance

    1 month ago

    Montréal, Canada NeuroRx Research Full time

    **The role**: The Quality Assurance / Quality Control Coordinator is part of NeuroRx’ QA Unit and is responsible for internal Quality Assurance (QA) monitoring activities as well as for Quality Control (QC) of MRI related data in our database. Duties of the Quality Assurance / Quality Control Coordinator include: - QC of quantitative measurement results...

  • Quality Assurance Leader

    4 weeks ago

    Montréal, QC, Canada Talasoft Full time

    Our client is seeking to recruit a Lead for the Engineering QA team. The successful candidate will play a crucial role in developing, enhancing, and maintaining our firmware/hardware QA infrastructure to support our expanding product line. This role requires someone with robust quality process management skills and expertise in both software and hardware...

  • Corporate Quality Assurance Manager

    4 weeks ago

    Montréal-Est, Canada Humanify Full time

    Job DescriptionCorporate Quality Assurance Manager Department: All  Location: Montreal (Travelling between sites)Reports to: Quality and Preproduction Director. On of our client, Balcan Innovations is a leading North American manufacturer of technical films, flexible packaging, and reflective insulation with five brands at its core: Balcan Packaging,...

  • Quality Assurance Specialist

    7 days ago

    Montréal, Canada CAMP Systems International, Inc. Full time

    OverviewCAMP Systems is the leading provider of aircraft compliance and health management services to the global business aviation industry. CAMP is the pre-eminent brand in its industry and is the exclusive recommended service provider for nearly all business aircraft manufacturers in the world. Our services are delivered through a “SaaS plus” model and...

  • Quality Assurance Analyst

    1 week ago

    Montréal, Canada Nurun Full time

    **Company Description**: We are Nurun, at the crossroads of creativity and technology. We create digital experiences that help to grow brands and transform organizations. We are hybrids who organize our work around multi-disciplinary collaboration. Our vision: humans first, technology second. Always the same ingredients, but never the same recipe: we adapt...

  • Quality Assurance Specialist

    7 days ago

    Montréal, Canada Safran Full time

    (English description to follow)Sur notre entrepriseSafran est un groupe international de haute technologie, présent sur les marchés de l'aéronautique (propulsion, équipements et aménagements intérieurs), de la défense et de l'espace. Safran est présent dans le monde entier, avec 76 800 employés, et est classé 28ème meilleur employeur au monde en...

  • Quality Assurance Specialist

    7 days ago

    montréal, Canada Safran Full time

    (English description to follow)Sur notre entrepriseSafran est un groupe international de haute technologie, présent sur les marchés de l'aéronautique (propulsion, équipements et aménagements intérieurs), de la défense et de l'espace. Safran est présent dans le monde entier, avec 76 800 employés, et est classé 28ème meilleur employeur au monde en...

  • Quality Assurance Specialist

    7 days ago

    montréal, Canada Safran Full time

    (English description to follow)Sur notre entrepriseSafran est un groupe international de haute technologie, présent sur les marchés de l'aéronautique (propulsion, équipements et aménagements intérieurs), de la défense et de l'espace. Safran est présent dans le monde entier, avec 76 800 employés, et est classé 28ème meilleur employeur au monde en...

  • Quality Assurance Analyst

    2 weeks ago

    Montréal, Canada Nurun Full time

    **Company Description**: We are Nurun, at the crossroads of creativity and technology. We create digital experiences that help to grow brands and transform organizations. We are hybrids who organize our work around multi-disciplinary collaboration. Our vision: humans first, technology second. Always the same ingredients, but never the same recipe: we adapt...

  • Quality Assurance Analyst

    2 weeks ago

    Montréal, Canada Nurun Full time

    **Company Description** We are Nurun, at the crossroads of creativity and technology. We create digital experiences that help to grow brands and transform organizations. We are hybrids who organize our work around multi-disciplinary collaboration. Our vision: humans first, technology second. Always the same ingredients, but never the same recipe: we adapt...

  • Quality Assurance Manager

    1 month ago

    Montréal, QC, Canada Brunel Full time

    Introduction We are seeking a proactive and experienced Quality Assurance Manager who is proficient in French and English to oversee and enhance our Client's food safety and quality systems. The ideal candidate will take ownership of maintaining the HACCP program and GFSI certification (BRC audit), ensuring all products meet regulatory standards and...

  • Manager, Customer Experience Quality Assurance

    2 days ago

    Montréal, Canada Grainger Canada Full time

    DESCRIPTION DE L'OFFRE **Primary Function**: The Manager, Customer Experience Quality Assurance leads the strategy, design and implementation of all Customer Service Center Quality Assurance policies, programs, and initiatives while leading a team of Customer Experience Quality Evaluators. The Manager establishes standards governing customer interactions,...