Publié il y a 36 mois
Specialist/Project Manager, quality assurance
@ FOP Consultants
Québec
En bref
FOP Consultants is hiring quality assurance consultants for medical device clients to review and approve quality documents, manage complaints, investigations and CAPA, and report KPIs. The role is a temporary or full-time consulting mandate with remote work offered according to client needs, and the posting offers group insurance, three weeks of vacation and continuing education.
Responsabilités :
- Revise and write quality documents such as SOPs and protocols
- Document customer complaints and open investigations
- Manage quality assurance projects
- Provide KPI data on business performance
- Carry out regulatory monitoring on medical device GMPs
Résumé des exigences :
- Bachelor's or master's degree in science or engineering
- One to ten years of medical device or pharmaceutical quality experience
- Knowledge of ISO 13485, FDA and Health Canada regulations
- Knowledge of medical device classes I, IIa, IIb and III
- Good French and English writing skills
Outils et compétences
Avantages mentionnés
Source et dates
Type de source non vérifié · jsonld
- Date publiée par l’employeur
- 2023-11-16
- Première détection par notre source
- 2026-10-26
- Mise à jour du dossier source
- 2026-11-09
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Intermédiaire |
| Domaine | Assurance qualité |
| Expérience | 1 an(s) et plus |
| Heures par semaine | 40 (estimé) |
| Milieu de travail | Bureau, Domicile |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English, French |
| Formation | Baccalauréat (exigé), Maîtrise (préféré) |
| Domaines d’études | medical technology, chemistry, biochemistry, biomedical engineering, mechanical engineering |
| Avantages mentionnés | Congés payés généreux, Aide au transport en commun |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
FOP Consultants
| Champ | Valeur |
|---|---|
| Offres sur Jobsy | 77 |
Brief description of the position :
In order to meet the needs of our customers in the Medical Devices sectors, FOP CONSULTANTS is looking for quality assurance consultants motivated to carry out mandates. The main missions would be to review and approve quality documents (SOP, protocols, etc.), collaborate on customer complaints, write non-conformity reports, investigation, change control, CAPA, present performance indicators and perform all quality assurance tasks related to medical devices.
Main responsibilities :
Without limitation, the main tasks involve:
- Manage projects related to quality assurance procedures and documentation;
- Revise and write quality documents (SOP, protocols, instructions, etc.);
- Document customer complaints and ensure that investigations are opened to resolve them;
- Provide KPI data to assess business performance;
- Act as a support to respond to requests on the quality of medical products;
- Carry out regulatory monitoring to learn about GMPs related to medical devices;
- Collaborate with teams from different departments to resolve quality issues related to deviations, change control, CAPA and investigations;
- Participate in any project to improve the quality assurance system;
- Participate in weekly or monthly meetings on regulatory files;
- Provide solutions to problems encountered and perform all tasks relevant to the mandate.
Qualifications :
- Bachelor's or Master's degree in science (medical technology, chemistry, biochemistry, etc.) engineering (biomedical; biomechanics, mechanics, physics) or any other related discipline;
- 1 (one) to 10 (ten) years of experience in the medical device, hospital or related industry;
- Project management (an asset);
- Experience in quality assurance in the field of medical devices, pharmaceuticals;
- Knowledge of ISO 13485 standards;
- Knowledge of FDA, Health Canada regulations;
- Knowledge of classes I, IIa, IIb and III of medical devices;
- Excellent command of MS Office suite;
- Good communication and writing skills in French and English;
- Mobility (an asset).
Personal skills :
- Leadership;
- Rigor et discipline;
- (Organize), able to manage several projects;
- Analytical and critical mindset;
- Perseverance;
- Humility.
What we offer :
In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:
- Competitive wages;
- Group insurance;
- Professional insurance;
- Remote work, according to the customer needs;
- Vacations: 3 weeks;
- Paid sick leave: 3 days;
- Monthly transportation fees;
- Career advancement opportunity;
- Continuing education.
Journal
Visible seulement par vous. Conservé sur cet appareil, et dans votre compte une fois connecté.