Quality Assurance Specialist

7 months ago

Montréal, Canada Endocision Technologies Inc. Full time

**Title**:Regulatory Affairs & Quality Specialist

**Reports to**: Director Regulatory Affairs and Quality Assurance

**Profile**:
The person will be responsible for the management and development of all quality and regulatory duties involving the following: ISO 13485, CE-Mark, Health Canada and FDA. The Regulatory Affairs & Quality Specialist will work closely with R&D and report to the Regulatory Affairs & Quality Director.

The individual has the ability to work in a changing and dynamic environment and can effectively collaborate in a team with the other departments.

**Quality**
- Write procedures, work instructions and other quality related documents.
- Maintain the risk analysis documentation.
- Maintain complaint log file.
- Maintain the CAPA and NCR log file.
- Maintain and issue training requirements to company.
- Monitor KPI’s as defined in the Quality Objectives.
- Ensure QMS remains up to date and be responsible for document control.
- Support R&D in the writing of test protocols, reports and other design control deliverables.
- Maintain and schedule the internal audit program. Participate in the execution of the internal audits as seen appropriate by the Director.
- Maintain all product incoming, in-process and final testing documentation.
- Maintain all product recall documentation.
- Maintain all Quality Management meeting documentation.
- Maintain working knowledge of ISO 13485 and ISO 14971.

**Regulatory**
- Compile dossier for regulatory submission (i.e., 510(k)).
- Maintain a log and a copy of all communications between the company and regulators.
- Assess changes for regulatory impact.
- Maintain in depth knowledge of regulatory guidance documents.
- Monitor revision to regulatory guidance documents and standards.
- Support RAQA Director in building and executing regulatory strategy.

**Qualifications**:

- Holds at a minimum a Bachelor of Science, Bachelor of Engineering or a Technical Degree in Engineering.
- A minimum of 3 years as a quality engineer, RAQA Specialist, Documentalist or Equivalent.
- 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.
- Bilingual with a strong written English.
- Experience in small self-organizing companies a plus.
- ISO 13485:2016 Lead Auditor certification a plus.

**What you will get at Endocision**:

- Competitive compensation and benefits package.
- A lean and nimble company culture.
- Access to a modern office space.
- Note: while we welcome remote working, this is a hybrid position with some regular presence at the office in Montreal expected.

**About Endocision**

Endocision is a medical devices company headquartered in Montreal, Quebec, that is developing innovative mínimally invasive cryogenic devices for lung disease diagnosis and treatment.

**Français**

**Titre **: Spécialiste des affaires réglementaires et de la qualité

**Se rapporte à**: Directeur des affaires réglementaires et de l'assurance qualité

**Profil**:
La personne sera responsable de la gestion et du développement de toutes les tâches liées à la qualité et à la réglementation impliquant les éléments suivants : ISO 13485, CE-Mark, Santé Canada et FDA. Le spécialiste des affaires réglementaires et de la qualité travaillera en étroite collaboration avec la R&D et rendra se rapportera au directeur des affaires réglementaires et de la qualité.

La personne a la capacité de travailler dans un environnement changeant et dynamique et peut collaborer efficacement au sein d'une équipe avec les autres départements.

**Qualité**
- Rédiger des procédures, des instructions de travail et d'autres documents relatifs à la qualité.
- Tenir à jour la documentation relative à l'analyse des risques.
- Tenir à jour le fichier journal des plaintes.
- Tenir à jour le fichier journal des CAPA et des NCR.
- Tenir à jour et transmettre à l'entreprise les exigences en matière de formation.
- Contrôler les indicateurs clés de performance tels que définis dans les objectifs de qualité.
- S'assurer que le QMS reste à jour et être responsable du contrôle des documents.
- Soutenir la R&D dans la rédaction de protocoles de test, de rapports et d'autres livrables de contrôle de la conception.
- Maintenir et programmer les activités d'audit interne. Participer à l'exécution des audits internes si le directeur le juge adéquat.
- Tenir à jour l'ensemble de la documentation relative aux produits entrants, aux produits en cours de fabrication et aux tests finaux.
- Conserver toute la documentation relative aux rappels de produits.
- Conserver toute la documentation relative aux réunions de gestion de la qualité.
- Maintenir une connaissance pratique des normes ISO 13485 et ISO 14971.

**Affaire Règlementaire**
- Compiler le dossier en vue de la soumission réglementaire (p.ex., 510(k)).
- Tenir un journal et une

  • Quality Assurance Specialist

    4 days ago

    Montréal, Canada Lansweeper Full time

    With the recent acquisition from Lansweeper, **Cloudockit** is rapidly expanding its global market and needs a Quality Assurance Specialist to join the Cloudockit product team. The responsibilities of the Quality Assurance Specialist include participating in the final stages of the software development life cycle. If you are equally happy to roll up your...

  • Quality Assurance Specialist

    7 months ago

    Montréal, Canada CTConsultants Full time

    **CTC007571 - Quality Assurance Specialist**: **Secteur industriel: Infrastructure**: **Type d'emploi: Contract**: **Durée: Eleven months**: **Mode de travail: Remote**: **Description**: Duration: 200 hours Possibility of extension: Yes Flexible hourly rate Remote: Hybrid. 10% in-office and 90% remote. Offices are in Montreal, Ottawa or...

  • Quality Assurance Specialist

    6 days ago

    Montréal, Canada Bento Sushi Full time

    Join Team Bento and be a part of our group of companies which operates more than 5600 locations globally. With operations across Canada and United States, Bento brings together a dynamic team of people with diverse backgrounds, experience, and talent, to create an exceptional guest experience. Come roll with us as a **Quality Assurance Specialist **and play...

  • Quality Assurance Specialist

    1 week ago

    Montréal, Canada Versacold Full time

    VersaCold is a food-first supply chain company with one of North America’s largest cold chain networks. We're dedicated to ensuring the safety, quality and freshness of the food families eat. With 65 years of experience, we collaborate as entrusted partners to maintain cold chain integrity and deliver customized solutions to complex business challenges....

  • Quality Assurance Specialist

    1 week ago

    Montréal, Canada Versacold Full time

    VersaCold is a food-first supply chain company with one of North America’s largest cold chain networks. We're dedicated to ensuring the safety, quality and freshness of the food families eat. With 65 years of experience, we collaborate as entrusted partners to maintain cold chain integrity and deliver customized solutions to complex business challenges....

  • Quality Assurance Specialist

    3 months ago

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

    CAMP is currently seeking a Quality Assurance Specialist to be located in our Wichita Kansas, Savannah Georgia, Ronkonkoma, New York, Clovis, CA, Merrimack, NH or Montreal office. **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...

  • Quality Assurance Specialist

    7 months ago

    Montréal, Canada Fundstream Full time

    **Title**: Quality Assurance Specialist **Status**: Permanent, Full Time (37.5h/week) **Annual Salary**: $47, 000 $ to $55, 000$ based on experience. **Starting Date**: As soon as possible, remote (onsite presence required as needed) Who are we? Fundstream is a leader in Canadian gift card marketing and fulfillment. Founded in 2003, Fundstream operates...

  • Underwriting Quality Assurance Specialist

    1 week ago

    Montréal, Canada Economical Insurance Full time

    **Underwriting Quality Assurance Specialist (Commercial Insurance Property & Casualty)**: Job ID : 5794 Category : Finance Brand : Economical Regular/Temporary : Regular Fulltime/Parttime : Full Time Location : Montreal, Canada

  • Quality Assurance Specialist

    1 week ago

    Montréal, Canada Mirametrix - A Lattice Semiconductor Company Full time

    **Join us!** **Quality Assurance Specialist** **What’s in it for you?** - 4 Weeks of Annual Vacation - 5 Personal Days - Subsidized Health and Dental Insurance - RRSP Matching Program - Bonus and Restricted Stock Programs - Fun and Open Work Environment - Hybrid Working Model - Employee and Family Assistance Program **What you’ll get to do**: -...

  • Quality Assurance Specialist

    7 months 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”...

  • Quality Assurance Specialist

    1 week ago

    Montréal, Canada Laces Group Inc. Full time

    QUALITY ASSURANCE SPECIALIST IMPORTER INC. - Montréal, QC Based in Montreal, Quebec with offices in New York, NY and New Castle, DE, Laces Group Inc. ("Laces" or the "Company") is a leading designer, marketer, manufacturer and distributor of everyday bath and home products. The Company sells its products to over 500 customers and over 35,000 storefronts in...

  • Quality Assurance Specialist

    1 month ago

    Montréal, QC, Canada L3Harris Technologies Full time

    **About your next** Challenge as a Quality Assurance Specialist**: **What will you do**: - Review documentation to ensure adherence to the required standards; - Assists in or conduct audits on internal business streams to ensure product conformance with quality requirements and business’s established procedures; - Support customer QA audits as required; -...

  • Quality Assurance Specialist

    7 months ago

    Montréal, Canada Equisoft Full time

    **Quality Assurance Specialist** **What is Equisoft?** Equisoft is a global provider of advanced insurance and investment digital solutions, recognized as a valued partner by over 250 of the world’s leading financial institutions. We offer a complete ecosystem of end-to-end and scalable solutions that help our clients tackle any challenge in this era of...

  • Specialist, Quality Assurance 1

    3 weeks ago

    Montréal, Canada VIA Rail Canada Full time

    Reference Number : 588 Status : Permanent - Full-time Annual Salary / Hourly Rate : $71 971 - $88 906 Number of positions to be filled : 1 Application Deadline : 01/17/2025 Did you know that VIA Rail is carrying out ambitious projects to modernize its services and infrastructure? From our new ultramodern train fleet to ongoing improvement of our...

  • Quality Assurance Specialist, Sterile Operations

    7 months ago

    Montréal, Canada Centre de production de produits biologiques Inc Full time

    The Biologics Manufacturing Center ( BMC ) Inc. is a new biomanufacturing facility created in response to the pandemic. A not-for-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC helps support projects of public interest, actively contributes to the overall growth and resilience of the Canadian life sciences...

  • Quality Assurance Specialist Ii

    2 days ago

    Montréal, Canada Certara Full time

    Overview: **At Certara, we accelerate medicines to patients by partnering with life science innovators.** - informed decision-making & reduced clinical trial burden - higher R&D productivity - improved patient outcomes & increased patient access to medicines - accelerated regulatory approval Certara is a global team that fosters and nurtures a diverse and...

  • Bilingual Specialist Ii, Quality Assurance

    4 weeks ago

    Montréal, Canada First National Financial Full time

    First National is proud to be an equal opportunity employer and is committed to diversity and inclusion regardless of race, color, religion, national origin, age, gender identity, physical or mental disability, sexual orientation or any other category protected by law. We are hiring a Bilingual Specialist II, Quality Assurance! **Reporting To**: Manager,...

  • Bilingual Call Centre Quality Assurance Specialist

    7 months ago

    Montréal, Canada Endo Networks Full time

    Endo Networks is an experiential marketing company. We are currently seeking a Bilingual Call Centre Quality Assurance Specialist to join our team. As a Bilingual Call Centre Quality Assurance Specialist, you will play a crucial role in ensuring the quality and reliability of our products and services, ultimately enhancing the customer...

  • Bilingual Specialist Ii, Quality Assurance

    2 months ago

    Montréal, QC, Canada First National Financial Full time

    First National is proud to be an equal opportunity employer and is committed to diversity and inclusion regardless of race, color, religion, national origin, age, gender identity, physical or mental disability, sexual orientation or any other category protected by law. We are hiring a Bilingual Specialist II, Quality Assurance! **Reporting To**: Manager,...

  • Spécialiste Assurance Qualité Quality Assurance

    1 week ago

    Montréal, Canada Symetris Full time

    **Description du poste** Poste à temps plein avec horaire flexible. Experts en technologie web depuis plus de 18 ans, Symetris se spécialise dans les projets numériques d’envergure. Nos clients nous choisissent pour bénéficier de l’ « Expérience Symetris » : notre encadrement accru, notre méthodologie de gestion de projet rigoureuse inspirée...