Quality Assurance Manager

2 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

    2 weeks 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

    3 weeks 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

    3 weeks 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

    3 weeks ago

    Montréal, QC, 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...

  • Quality Assurance Manager

    2 weeks ago

    Montréal, Canada Culture Kizos Full time

    **Job description** **Job Summary** The Quality Assurance Manager is responsible for Good Production Practices (GPP) according to Health Canada and Good Manufacturing Practices within the company Quality Management System (GMS). Integrate, oversee, maintain and report conformance status in all areas. **Role and responsibilities** - Assess, interpret, and...

  • Quality Assurance Manager

    2 weeks ago

    Montréal, Canada Sensio Inc Full time

    **QUALITY ASSURANCE MANAGER** We are seeking a Quality Assurance Manager to manage our quality system strategy by formalizing and implementing a cohesive quality system with our teams in Montreal and Asia. You will be supporting quality initiatives for a fast growing organization with multiple in house and private label brands. We are looking for someone...

  • Quality Assurance Manager

    3 weeks ago

    Montréal, Canada Bureau Veritas Full time

    Do you believe in the power of teamwork and sharing ideas? Do you take pride in delivering exceptional quality and service with everything you do? Do you seek out ideas for improving the status quo? If you want to make a difference and love being surrounded by the best and the brightest, Bureau Veritas Laboratories might be the place for you! **Imagine...

  • Assurance Quality Manager

    3 weeks ago

    Montréal, Canada FTAI Aviation LLC Full time

    **About us**: FTAI Aviation Ltd. (NASDAQ: FTAI) is a leading provider of maintenance and support for commercial jet engines, particularly the CFM56 and V2500 models. We specialize in offering innovative solutions that help our airline, lessor, and maintenance customers reduce costs and increase flexibility. We own and lease jet aircraft, enabling us to...

  • Quality Assurance Manager

    1 week ago

    Montréal, Canada Vetio Animal Health Canada Full time

    Vetio Animal Health is a rapidly growing Contract Development and Manufacturing Organization (CDMO) dedicated to animal health; we integrate product development with full-scale pharmaceutical manufacturing through a Quality-by-Design process. Our mission is to develop and manufacture products that improve the lives of animals, while ensuring the safety,...

  • Quality Assurance Manager

    2 weeks ago

    Montréal, QC, Canada Camp Systems International Inc. Full time

    **Overview** CAMP 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”...

  • Quality Assurance and Purchasing Manager

    2 weeks ago

    Montréal, Canada CUCINA Fine Foods Full time

    **About us** We are professional, agile, inclusive, and our goal is to source the best foods of Italy and Europe and share them with our discerning clients. Our work environment includes: - Modern office setting - Food provided - Modern office setting - Work-from-home days - Growth opportunities - Regular social events - Casual work attire - International...

  • Quality Assurance Analyst

    2 weeks ago

    Montréal, Canada MaintainX Full time

    MaintainX is the world leading mobile-first workflow management platform for industrial and frontline workers. We are building the GitHub for real world workflows such as maintenance, safety and operations and improving operational efficiency for 2,000+ businesses including Univar, Quikrete, ABInBev, Duracell, Marriott and McDonald's. We've raised $54...

  • Specialist, Quality Assurance

    1 week ago

    Montréal, Canada Lundbeck Full time

    We are currently looking for a qualified Specialist, Quality Assurance to join the Lundbeck Canada Quality Assurance team. This position is permanent full-time located at our Ville Saint-Laurent head-office. The incumbent will report to the Senior Director, Quality Operations US. Lundbeck Canada offers comprehensive benefits to its employees, including...

  • Quality Assurance

    2 weeks 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...

  • Associate, Quality Assurance

    3 weeks ago

    Montréal, Canada ROSE LIFESCIENCE INC Full time

    **We’re looking for great people.** Specifically, we’re looking for you to reimagine cannabis with us. We love where we work, we believe in each other, and we learn new things every day. We’ve been doing it since 2016 and have now become Québec’s most innovative cannabis company by leading our industry, developing game-changing products, and...

  • Quality Assurance Manager

    3 weeks ago

    Montréal, Canada On Side Restoration Full time

    On Side Restoration is looking for an experienced Quality Assurance Manager (QA Manager) to join our team in Quebec! The QA Manager works with stakeholders to resolve escalated situations involving customers and clients. With customer service as a top priority, the QA Manager ensures customer feedback is acknowledged, documented, reported, and investigated....

  • Quality Assurance Manager

    1 week ago

    Montréal, Canada OpenBet Full time

    Company Description **OpenBet is sport**. The world's top **sports betting** brands choose OpenBet as their partner for world class content, **leading tech** and tailored services. We have their back. So they’re ready with exciting, memorable and safe sports betting experiences, to entertain millions of players worldwide. OpenBet’s mission is to **power...

  • Quality Assurance Specialist

    2 weeks ago

    Montréal, Canada Novatek International Full time

    **Location**:Montreal, Quebec **Position**:Full Time **Start Date**:Immediate Are you passionate about product quality? Are you driven by using your skills to solve problems for users? Are you interested in being part of the team that helps improve quality of the pharmaceutical products that we use every day? Novatek International is looking for creative...

  • Quality Assurance Lead

    2 weeks ago

    Montréal, Canada LifeWorks Full time

    Build a meaningful career At LifeWorks, we offer more than career opportunities, we provide career opportunities to make meaningful contributions to people’s lives. The extraordinary expertise of a more than 7,000-strong workforce is harnessed to support the employees and families of the organizations we serve. Our innovative programs have a lasting...

  • Quality Assurance Specialist

    3 weeks ago

    Montréal, Canada Camp Systems International Inc. Full time

    **Overview** CAMP 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”...