Iso 13485 Internal Auditor
5 days ago
**Job Description for ISO 13485 Internal Auditor**
This position is an ideal opportunity for a Quality professional who is looking for a job with a great deal of variety, enjoys coaching people, making decisions and being a team leader.
**The Company**
We are a Canadian contract electronic design and manufacturing company. Our quality system is certified to ISO 9001 and ISO 13485. We design and manufacture medical instruments, machine controls, vending machine controls and much more. We are looking for an ISO 13485 Internal Auditor to join our team.
**Duties.**
The successful applicant will be responsible for carrying out the following activities.
- Internal Auditing to ISO 13485 and ISO 9001
- Weekly Production KPI reporting
- Engineering department weekly inspection and KPI
- Carry out a weekly inspection of workstation cleanliness and adherence to 5S standards
- Closing project quality documents at the end of a job
- Confirming that components used on each production job meet ROHS and REACH requirements
- Carry out regular ESD inspection
- Compile quality packs for customers at the end of each production and design job
- Complete quarterly quality analysis for presentation at company quarterly meetings
- Provide support for external and customer audits (BSI, TUV, etc.)
- Issue and close CAPA/SCAR
- Act as a 5S leader
- Resolving interdepartmental issues
- Taking part in our management meetings
- Carry out any other tasks required by our Quality Department and management team
**Qualifications**
- Quality Assurance - Manufacturing and Management course or equivalent
- Training as an ISO 9001 internal auditor
- Training as an ISO 13485 internal auditor
- Excellent written and verbal communication skills
- Ability to lead and direct staff to meet all quality system requirements
The following will be an asset
- Experience in quality management in an electronic manufacturing environment
- Knowledge of surface mount assembly and through hole assembly processes
**Job Types**: Full-time, Permanent
**Salary**: $34.00-$40.00 per hour
**Benefits**:
- Dental care
- Disability insurance
- Extended health care
- Flexible schedule
- Life insurance
- Profit sharing
- RRSP match
Schedule:
- 8 hour shift
- Monday to Friday
COVID-19 considerations:
Vaccine mandate. Mask wearing is optional
**Education**:
- Bachelor's Degree (required)
**Experience**:
- quality assurance: 3 years (required)
Work Location: One location
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