Specialist Investigation, Quality Assurance

2 weeks ago

PointeClaire, Canada Medicom Full time

**JOB SUMMARY: -**

Responsible for the site finished product and incoming material investigations
- Responsible for the site CAPA system
- Responsible for the quality complaint investigations

**EDUCATIONAL & TRAINING REQUIREMENTS**:
**REQUIRED: -**

Minimum D.E.C in sciences or in any other pertinent technical discipline

**ASSET: -**

Knowledge of ISO standards and regulatory requirements for medical devices (Canada and USA)
- Knowledge of Good Manufacturing Practice (GMP) requirements
- Certificate in Quality Assurance or knowledge of Root Cause Analysis methodology
- Technical knowledge of similar types of medical devices

**EXPERIENCE**:
**REQUIRED: -**

A minimum of 1 years of progressive experience in a GMP (Good Manufacturing Practices) environment, in the pharmaceutical or medical devices industry, or closely related field

**KNOWLEDGE & SKILLS REQUIREMENTS**:
**REQUIRED: -**

Detail oriented, accurate and reliable
- Good written and verbal communication skills in both English and French
- Ability to make sound quality decisions
- Ability to work in a dynamic environment with multiple priorities and meet deadlines
- Demonstrate the Medicom core values of Teamwork, Accountability and Customer Centricity.

**KEY RESPONSIBILITIES**:
**1. RESPONSIBLE FOR THE SITE INVESTIGATIONS -**

Ensure timely creation, writing, tracking and closure of investigations
- Execute thorough analysis including accurate problem identification, definition of immediate actions, root cause analysis, risk assessment and CAPA identification
- Write and defend in audits clear, concise, and complete investigation
- Perform investigation trending analysis
- Compile and maintain performance metrics (KPI) to ensure adequate performance of the investigation
- Review other investigations and coach colleagues based on best practice

**2. RESPONSIBLE FOR THE SITE CAPA SYSTEM -**

Ensure timely creation, tracking and closure of CAPAs
- Perform thorough and periodic CAPA follow-ups
- Write and defend in audits clear, concise, and complete CAPA Reports
- Measure CAPA effectiveness
- Perform CAPA trending analysis
- Compile and maintain performance metrics (KPI) to ensure adequate performance of the CAPA system
- Review other CAPAs and coach colleagues based on best practice

**3. SUPPORT SITE QUALITY COMPLAINT INVESTIGATIONS -**

Ensure adequate communication and timely follow ups with costumer service and the complainants
- Perform an appropriate categorization and evaluation of the complaints based on a risk analysis approach
- Work with Regulatory Affairs for timely Adverse Event reporting
- Ensures adequate supplier investigation or sample evaluation
- Provide a comprehensive response to complainants in a timely manner
- Participate in complaint trending analysis and product quality improvement activities.

***

**...**

**SOMMAIRE DU POSTE**:

- Responsable des enquêtes sur les produits finis et les matériaux entrants du site.
- Responsable du système CAPA du site
- Responsable des enquêtes sur les plaintes relatives à la qualité

**NIVEAU DE SCOLARITÉ & PERFECTIONNEMENT REQUIS**:
**REQUIS**:

- Minimum D.E.C. en sciences ou dans toute autre discipline technique pertinente.

**ATOUT**:

- Connaissance des normes ISO et des exigences réglementaires relatives aux dispositifs médicaux (Canada et États-Unis).
- Connaissance des exigences des bonnes pratiques de fabrication (BPF)
- Certificat en assurance qualité ou connaissance de la méthodologie d'analyse des causes profondes
- Connaissance technique de types similaires de dispositifs médicaux

**EXPÉRIENCE**:
**REQUIS**:

- Un minimum de 1 an d'expérience progressive dans un environnement GMP (Good Manufacturing Practices), dans l'industrie pharmaceutique ou des dispositifs médicaux, ou dans un domaine étroitement lié.

**HABILETÉS & CONNAISSANCES REQUISES**:
**REQUIS**:

- Souci du détail, précision et fiabilité
- Bonne capacité de communication écrite et verbale en anglais et en français.
- Capacité à prendre des décisions judicieuses en matière de qualité
- Capacité à travailler dans un environnement dynamique avec des priorités multiples et à respecter les délais.
- Démontrer les valeurs fondamentales de Medicom, soit le travail d'équipe, la responsabilisation et le souci du client.

**PRINCIPALES RESPONSABILITÉS**:
**1. RESPONSABLE DES ENQUÊTES SUR LE SITE**
- Assurer la création, la rédaction, le suivi et la fermeture des enquêtes en temps opportun.
- Exécuter une analyse approfondie, y compris l'identification précise des problèmes, la définition des actions immédiates, l'analyse des causes profondes, l'évaluation des risques et l'identification CAPA
- Rédiger et défendre dans les audits une enquête claire, concise et complète
- Effectuer une analyse des tendances de l'enquête
- Compiler et maintenir les mesures de performance (KPI) pour assurer une performance adéquate de l'enquête.
- Examiner d'autres enquêtes et conseill

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