Quality Specialist

2 weeks ago

North York, Canada Thornhill Medical Full time

**ABOUT THORNHILL MEDICAL**:
***:
The _**Quality Specialist**_ is responsible for leading and /or assisting in the daily operational management of the quality system in compliance with quality and regulatory requirements; designing and maintaining quality standards and processes; and determining corrective actions. The position works with various stakeholders to implement quality measures during design and in production.

**DUTIES & RESPONSIBILITIES**:

- Assists in the management and maintenance of the Quality Management System in compliance with ISO 13485 + MDSAP, CMDR, European MDD/MDR, US FDA QSR country specific requirements.
- Monitors, trends, and analyzes quality and product performance, and offer recommendations based on those analyses. Assists with any resulting health and hazard evaluation.
- Leads internal and supplier audits including creating audits plans, audit reports and closing out audit findings.
- Leads the material review board, assists with the investigation and troubleshooting of product and/or production issues. Reviews nonconforming product reports to ensure timely disposition of product.
- Coordinates the customer complaints process.
- Provides Root Cause Analysis, leadership and assist other departments in the resolution of customer feedback, complaints, and service.
- Develops corrective actions, solutions, and improvements including coaching internal stakeholders to complete that. Maintains supplier quality agreements. Assists with quality input to supplier approval process.
- Interfaces with Engineering and Operations to ensure design transfer process are in accordance with approved requirements.
- Responsible for certain KPIs and measures with regards to an improved product quality during development and production.
- Alerts management for all items affecting product quality/functionality in a negative manner.
- Assists in preparation for external regulatory audits.
- Conducts audits, including closing out audit findings, creating audits finding reports.
- Coaches, motivates, and communicates quality management focus cross-functionally to facilitate the achievement of quality deliverables.
- Collaborates with design teams and operations managers to develop and implement controls and improvements.
- Presents and/or chairs quality focused meetings and drive consensus/buy-in across multiple disciplines.
- Leads or supports continuous improvement projects, with a focus on quality and process improvements using problem solving methodologies such as: Kaizen, FMEA and Six Sigma.
- Considers quality in all aspects of the job and respects procedures and norms.
- Other duties as assigned.

**EDUCATION & EXPERIENCE**:

- Bachelor’s degree in engineering or science or related field.
- 3-5 years of related experience in Mechanical or Electrical Engineering or in a manufacturing/production environment.
- 2+ years of experience with ISO 13485 + MDSAP, European MDD/MDR, US FDA QSR requirements.
- Experience in quality management compliance at a medical device company with HC Class II and III devices is an asset.
- Experience interpreting quality data and presenting to management.
- Experience using quality systems.

**SKILLS & KNOWLEDGE**:

- Strong analytical skills.
- Ability to build strong relationships and work collaboratively with cross-functional teams to meet shared objectives.
- Ability to work under pressure at times managing a wide variety of activities.
- Meticulous and detail oriented.
- Excellent interpersonal and communication skills (verbal and written).
- Strong time management and organizational skills.
- Drive to consistently achieve results, even under tough circumstances.
- Excellent problem solving and troubleshooting skills.
- Self-starter that is highly motivated, creative, and able to work both independently and within a team environment.
- Strong computer skills and proficient knowledge of Microsoft Suite (Word, Excel, PowerPoint).

**OTHER REQUIREMENTS**:

- Primarily office environment with exposure to production work rooms when required.
- Light lifting and bending.
- **We thank all applicants for their interest, however, only those selected will be invited for an interview.**_

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

**Benefits**:

- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- On-site gym
- On-site parking
- Paid time off
- Vision care

Schedule:

- Monday to Friday
- Morning shift

Supplemental pay types:

- Bonus pay

Application question(s):

- What are your salary expectations?

**Education**:

- Bachelor's Degree (required)

**Experience**:

- QA/QC: 3 years (required)

**Language**:

- English (required)

Work Location: In person

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