Specialist 1, Quality

6 days ago

Montréal, Canada Agile MV Full time

**Overview**
Reporting to the Senior Specialist, Quality, Team Lead, this member of the Quality team supports the administration of the quality system within the company. As such, ensures the continuity of activities needed to operate the quality system and ensures successful audits by the Registrar. Ensuring the smooth running of all operations activities in line with ISO 13485, FDA, GMPs, CE mark such as the following tasks.

**Responsibilities**
- Ensure product compliance in accordance with the quality management system (QMS) and applicable regulatory requirements.
- Collaborate with internal departments, such as biomedical innovation and manufacturing to ensure the development and manufacturing of medical devices according to QMS and regulatory requirements.
- Contribute to the design control and risk management processes.
- Interpret the standards and regulations (mainly ISO13485, 21CFR 820, CMDR, MDR) and ensure QMS compliance.
- Compile and monitor indicators.
- Monitor actions resulting from audits, management review, or other sources.
- Perform internal and external audits.
- Support the corrective and preventive actions, complaints, and nonconformity reports.
- Perform change control and document control activities.
- Contribute to the equipment maintenance and calibration system.
- Monitor cleanroom parameters and testing.
- Contribute to suppliers’ quality assurance.

**Required**
- Graduated with a bachelor’s degree in engineering, Physical Sciences, or equivalent experience.
- Minimum of 5 Years of experience in the quality management system.
- Perfect knowledge of ISO 13485 and ability to interpret it in different settings to use.
- Good knowledge of Microsoft Office tools (Word, Excel, Visio, PowerPoint, Outlook)
- Knowledge of problem-solving tools (Brainstorming, Ishikawa, Pareto), an asset
- Knowledge of 6 sigma approach, an asset
- Has an inquiring mind and synthesis.
- Advanced level of oral and written French.
- Advanced level of English, to interact with customers and suppliers who are mainly international. To comply with international industry standards.

**Job Types**: Full-time, Permanent

Pay: $70,000.00-$80,000.00 per year

**Benefits**:

- Dental care
- Life insurance
- RRSP match

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- quality assurance: 3 years (preferred)

Work Location: In person

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