Medical Device Companies jobs in Ontario

Overview

Reporting to the Director RA & QA, the Manager, Validation & Verification will contribute to and provide support to all departments responsible for the design, development, manufacture and support of all products. This position shall oversee and complete all testing activities during development while maintaining a strict adherence to prescribed testing guidelines and quality management system procedures.

Key Accountabilities and Responsibilities

• Hands-on testing, managing and overseeing the entire process of testing in all phases of product development including:
• Developing, maintaining and executing verification procedures for specified product requirements
• Developing and maintaining and executing validation procedures that ensure user needs are met by products
• Ensuring verification and validation test procedures are properly executed
• Managing Verification & Validation Team members and their activities
• Analyze test results and defect data to identify problematic device features, and to report on status and product stability
• Manage all test records from verification and validation test activities
• Identify and recommend opportunities for improvement for the Verification & Validation Team and its processes, including increased use automated testing processes
• Provide support to Engineering as requested with product development and project management activities
• Report variances from the target completion date of project tasks, or that the tasks cannot be completed as early as possible
• Identify and report corrective actions as early as possible
• Assist other departments as required to develop and review written procedures
• Work effectively in collaboration with staff across the organization
• Relentlessly pursue continuous improvement opportunities to make products very reliable
• Other duties as assigned by management

Knowledge, Skills, and Experience Required

Education:

• A post-secondary degree/diploma in Science, Engineering or a related discipline
• Quality Assurance certifications are an asset

Knowledge and Experience:

• Minimum 6+ years progressive experience in a Verification & Validation Testing environment working with medical devices, medical software, imaging systems and/or analytical instrumentation
• Experience managing a team, including directing, evaluating and mentoring
• Thorough understanding of test methodology, including test plans, system and integration level testing, and status reporting
• Experience using automated test tools is essential. Implementing an automated test system is an asset.
• Hands-on experience with Software testing, Bug Fixes/Analysis, logging defects in defect tracking systems, assisting in developing and executing test procedures, maintaining and analyzing test results is desirable
• Knowledge of global & quality standards such as ISO 13485 Quality Management System and IEC 62304 Medical device software — Software life cycle processes
• Experience with risk assessment and management using formal procedures or regulatory standards such as ISO 14971 is desirable
• Thorough understanding of traceability between risks, product requirements, product design, implementation, test procedures, test results, and risk mitigations
• Basic knowledge of software, electronics and complex systems is an asset
• Experience with all aspects of product development is desirable
• Experience in working with eQMS/ERP systems is desirable
• Proficiency using office productivity software (Microsoft Office, etc) for communication and documentation purposes

Pay: $110,000.00-$120,000.00 per year

Work Location: In person