Quality Engineer I
12 months contract
The individual will support the Quality Manager in a variety of day-to-day quality and compliance-related tasks, projects, audits, and improvements. In so doing, the individual will gain an understanding of the many aspects of control and compliance required to operate an accredited test laboratory in a regulated medical device development environment.
Roles and Responsibilities
• Review test plans and test reports for compliance with Good Documentation Practices.
• Assist in the control/monitoring of equipment preventive maintenance and health checks.
• Assist in the review of the Quality Manual and associated procedures.
• Assist in the creation and/or modification of governing procedures.
• Assist in the verification/documentation of vault contents.
• Assist with internal audits.
• Review sub-contractor files for compliance with ASRC procedures.
• Longer-term: Assist in the alignment of multiple Quality Management Systems.
• Longer-term: Assist in the migration of training management to an e-tool.
• Longer-term: Assist in the migration of equipment preventive maintenance control to an e-tool.
• Longer-term: Explore e-capture of test equipment IDs and calibration information.
• 1-3 years relevant experience preferred.
• Undergraduate degree and/or technical training.
• Engineering, computer science, other technical, and/or quality-related training.
• Rigorous and attentive to detail.
• Good writing and documentation skills.
• Teamwork and good interpersonal communication skills.
• Proficient with Microsoft WORD, EXCEL, POWERPOINT.
• Available to work full-time (40 hours per week).