Quality Assurance Technician

Sotera Health • Laval, QC

112d

About The Position

Reporting to the Quality Assurance (QA) Manager, the Quality Assurance Technician is responsible for assisting the QA Manager in ensuring the quality system requirements are met and maintained. This role assists in providing management with information and data on all key aspects of the day-to-day operation, which is used by both plant and corporate management to determine if the quality system is adequate and operating as designed. The QA Technician must effectively interface with Customer Service, Sales, Operations, Maintenance and other plant and corporate staff, as well as customers and regulatory personnel.

Requirements

• Minimum university degree from a Canadian university degree, or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a physic or chemistry or biology or Engineering.
• Minimum of 2 years’ experience in Quality Assurance in a GMP medical devices or drug company.
• Must be bilingual in English and French

Nice To Haves

• Experience of 1 year in product release or in sterilization environment preferred.
• Good knowledge of GUI-0001 and FDA CFR 21 part 820.
• Experience in performing quality audits, both internal and suppliers, would be an asset.
• As part of the Quality Assurance team, capable of building and facilitating a quality culture with all employees.
• Strong communication and interpersonal skills
• Should be proficient using a computer and be able to analyze data in a database/spreadsheet
• Must be used to high workload

Responsibilities

• Redact of Procedures, deviation, change control and CAPA
• Redact validation protocol and report
• Manage the irradiation instruction specifications and determination of cycle time
• Manage the pest control program
• Manage the material inspection and inventory
• Manage the equipment preventive maintenance program
• Performs the batch review and release of certificate and product (except for DEL’s products)
• Performs density studies on customer products and complete applicable tote loading diagrams
• Measurement of Alanine Tapetabs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level