Title: Quality Associate
Location: Toronto, ON
Type: Contract, C2C & W2
Duration: Long Term
Job ID: 2412-001QA
The Quality Associate will assist in the implementation of procedures and processes for an ISO 13485:2016 compliant Quality system.
The QA associate will for work to ensure that processes, associated documents, equipment, software and computerized systems used in quality system carried out per established procedures and are controlled, qualified, verified and/or validated as required. Additionally, the individual will be responsible for the review of equipment calibration, maintenance requirements and developing records as needed for the control of equipment.
- Role includes implementing procedures and protocols to support verification and validation of the processes and tools used in the ISO 13485 compliant quality system.
- Writing, reviewing and executing IQ/OQ/PQ protocols and requirement documents for various process and associated equipment, including software, computerized systems and facilities within various development labs or manufacturing environments.
- Working with individuals from various departments to ensure compliance of above processes and associated equipment, software, computerized systems and environmental condition in use.
- Maintaining the product tractability matrix, reporting deviations, writing verification reports, memos, amendments, and addenda
- Assess and review equipment requirements to determine requirements for control, calibration, maintenance and validation where necessary.
- Assisting in collection, analysis and trending of data to support identified metrics for product and process performance.
- Assist in the preparation of technical files for submission by assisting with document management activities
Requirements & Preferred Skills:
- Minimum of 1 years of experience in the biotech/medical device environment; experience with writing verification test protocols, IQ/OQ/PQ protocols and summary reports; hands-on experience validating software to meet 21 CFR Part 820 and part 11 compliances a plus.
- Demonstrates the ability to write system and module acceptance test strategies and approaches for independent verification and validation of target applications.
- Must possess document and data analysis/management skills.
- Demonstrates the experience and ability to design and develop detailed test procedure with specifications.
- Highly motivated, conscientious, self-managed team player
- Strong problem solving skills and proven technical competency
- Possesses superior oral and written communications skills to clearly and effectively convey issues, reports, and other deliverables
- High attention to detail and excellent organizational skills
- Basic knowledge of GMP (Good Manufacturing Practice), GMP, ISO 13485, ISO 14971:, CMDCAS and EU MDD regulations
- Strong proficiency with Microsoft Office productivity suite
- Bachelor’s Degree in a scientific discipline or engineering; certification a plus