Quality Assurance Specialist

5 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

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