Quality Specialist
Quality Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Union: Non-Union
Number of vacancies: 1
Site: 3505 Laird Road Unit #16 Mississauga ON
Department: Quality and Regulatory
Reports to: Quality Manager
Status: Permanent Full-Time
Position Summary:
The position of Quality Specialist will be an integral member of the Quality and Regulatory department. The Quality Specialist will contribute to the development and maintenance of manufacturing and quality system procedures and work instructions to ensure compliance with global regulations and standards in a regulated medical device environment. The ideal candidate has at least 3 years of experience working in an Active Medical Device environment adhering to GMP with a good working knowledge of ISO 13485 and ISO 14971 FDA EU and HC regulations. The Quality Specialist will be part of the team supporting the company-wide transition to a new facility.
Primary responsibilities include:
- Contribute to the development and maintenance of manufacturing and quality system procedures and work instructions to ensure company compliance with global regulations and standards.
- Ensure the routine maintenance of QMS records and metrics analysis of production suppliers processes equipment and environment.
- Initiate track progress and contribute to resolution of complaints CAPAs deviations non-conformances and supplier corrective actions.
- Review and approve product specification sheets and incoming inspection records.
- Participate in internal and external quality system audits.
- Review and complete Device History Record (DHR) for product release approval.
- Report to Management on the performance (metrics) of the production Quality Management System.
- Train and maintain training records for company personnel.
- Contribute to developing training programs for company personnel.
- Manage production equipment maintenance and calibration schedules addition of new equipment and investigation of equipment failures.
- Maintain supplier records and perform supplier qualification and evaluation activities including on site audits.
- Assist with the routine production inspection and end-of-line testing.
- Review and approve test records.
- Provide oversight of facility environmental monitoring
- Assist engineering team with production issues debugging and root cause analysis.
- Spearhead quality improvements initiatives to improve production yield.
- Other duties as assigned.
Qualifications :
- Excellent organizational and time management skills
- Strong communication skills and technical writing skills
- Ability to work effectively in a team environment
- Ability to exercise initiative and good judgement with ability to multitask
- Ability to function independently with a high level of attention to detail
- Ability to prioritize multiple projects simultaneously
- Excellent interpersonal and communication skills
- Good working knowledge of ISO 13485 and ISO 14971
- Good working knowledge of FDA and EU regulations
- Experience working in GMP- Good Manufacturing Practice environments
Education:
- Minimum or B. Eng. in engineering or life sciences discipline
- Quality (ASQ) or other certifications an asset
Experience:
- Three (3) or more years of experience working in a healthcare/medical device production environment
- Experience working in a cleanroom/controlled environment is an asset
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
