Quality Engineer Jobs in London, Canada at Medicomp Inc
About Medicom
Do you think you have what it takes to work in an organization where creativity, ambition and initiative are valued, and where integrity drives everything we do?
Medicom has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company’s continued growth. We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.
Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being. We offer an attractive compensation package with benefits.
The Opportunity
The Quality Engineer will collaborate, lead, and support cross-functional teams on the quality and regulatory requirements to ensure company and industry compliance with requirements throughout the product lifecycle. The Quality Engineer is responsible for supporting and leading activities within the quality management system as well as participating in cross-functional team projects.
This posting is for a newly created position to support our continued growth.
What You Will Do
Quality System Management
Assist with the development and implementation of a robust and compliant quality management system (QMS) aligned with industry standards including ISO 13485:2016 and the Canadian Medical Devices Regulations (CMDR).
Support the maintenance and updating of quality procedures, and documentation as required.
Assist with conducting internal audits to identify areas for improvement and ensure compliance.
Product Development Support
Actively participating in cross-functional product development teams, ensuring quality is integrated into design and manufacturing processes from concept to design transfer and launch.
Reviewing design documents, specifications, and risk assessments to identify potential quality issues.
Supporting the development and execution of process validation and verification protocols and procedures.
Supplier Quality Management
Support Purchasing with the evaluation and approval of suppliers for raw materials and services to ensure they meet quality and company requirements.
Managing supplier quality issues and implementing corrective actions.
Non-Conformance and Corrective and Preventive Action
Investigating non-conforming materials and products, identifying root causes, and implementing corrective and preventive actions, as appropriate, following the CAPA procedure to prevent recurrence.
Managing the non-conformance reporting system and ensuring timely resolution of issues.
Manage customer complaints including trending and follow-up actions as required.
Quality Assurance
Activities:
Analyzing quality data to identify trends and implement continuous improvement initiatives.
Assist with employee training activities to support site training plan.
May include other related duties as required, provided such duties are reasonable and consistent with the employee’s qualifications and role responsibilities.
What You Bring
Minimum 3 years’ experience in medical device quality management systems, or relevant fields
Bachelor’s degree in Engineering or related field
Solid knowledge of ISO 13485, FDA regulations, and other applicable quality and regulatory standards within medical device or PPE manufacturing environments
Proficiency in quality analysis and problem-solving methodologies (e.g., root cause analysis, CAPA, continuous improvement tools) to drive product and process improvements
Strong communication and interpersonal skills, with the ability to effectively collaborate across cross-functional teams (Operations, Engineering, Quality, Supply Chain)
Demonstrated experience leading quality initiatives, with a focus on continuous improvement and operational excellence
Excellent organizational and prioritization skills, with the ability to manage multiple stakeholders and project timelines effectively
Ability to thrive in a fast-paced, project-based environment, demonstrating adaptability and resilience under pressure
High level of attention to detail,…
Title: Quality Engineer
Company: Medicomp Inc
Location: London, Canada
Category: