Quality Coordinator

1 week ago

North York, Canada Raz Design Inc. Full time

We are a small medical device manufacturer located in North York. We are looking for an hands-on individual to join our quality team and help maintain our compliance with ISO 9001, ISO 13485 and EU’s Medical Device Regulations.

**Position**: Quality Coordinator
**Reports to**:Quality Assurance and Regulatory Affairs (QARA) Manager
**Status**: Full-time position
**Salary**: Commensurate with experience

**Responsibilities**:

- Help maintain company’s compliance with ISO 9001:2015 and ISO 13485:2016
- Supervise QC related activities including outbound / inbound inspection based on AQL sampling
- Perform various dimensional check, visual inspection, sorting and data entry
- Generate non-conformance reports or return goods authorization reports for any defect found in incoming parts
- Produce statistical quality reports and analyze to identify trends
- Ensure all testing equipment are calibrated
- Support production by resolving quality issues
- Coordinate with Supply Chain for incoming QC priorities
- Drive continuous improvements within the QA / QC programs
- Issue organization Quality Alerts to promote best practices
- Follows all employee policies, QMS procedure and other company processes
- Other quality assurance / control duties as required by the QARA Manager

**Qualifications and Skills**:

- Quality Management education (college diploma or higher with Mechanical Engineering preferred)
- Minimum 2 years work experience in a manufacturing environment in a QA / QC position (medical device experience is preferred)
- Proficient in the use of the 7 Basic Quality Tools - ASQ for process improvement
- Ability to read, interpret and understand mechanical engineering drawings with GD&T
- Experience in issuing SCARs will be an asset
- Must have good written and verbal communication skills in English
- Must be proficient working with Microsoft Excel and Word
- Must be able to lift 40 lbs
- Ability to work independently and as part of a team, managing multiple priorities
- Must have a high attention for detail
- Able to work in a fast paced and time-sensitive environment
- Positive attitude, self-motivation and result oriented

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

**Benefits**:

- Casual dress
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Wellness program

Flexible Language Requirement:

- French not required

Schedule:

- Day shift
- Monday to Friday
- Overtime

Supplemental pay types:

- Bonus pay
- Overtime pay

Ability to commute/relocate:

- North York, ON M3A 1B7: reliably commute or plan to relocate before starting work (required)

**Education**:

- AEC / DEP or Skilled Trade Certificate (preferred)

**Language**:

- and write English fluently (required)

Work Location: In person

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