Manager, Quality Systems Jobs

At NDI, our mission is built around using our measurement technologies to improve medical procedures and patients’ lives. This requires product innovation that is achieved through fostering collaboration, trust, and strong relationships. At NDI, you will work with talented people who are ready and willing to push their limits in an environment where learning and exploring new ways of doing things is valued as much or more than experience. We are proud of our heritage, culture and international growth over the past 41 years and are honoured to be a valued partner with the world’s leading medical companies.
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Role Summary:
As the Manager, Quality Systems, you will provide leadership and support for the maintenance and continuous improvement of the Quality Management System.They will lead and manage all audits performed at NDI including vendor, customer, 3rd party and internal audits. In addition, they will be responsible for managing CAPA-related activities.
Scope of Responsibilities:
QMS Management 

• Lead and direct team members to assist in maintaining the Quality management system.
• Lead all Audit activities ensuring evidence is retained.
• Act as administrator for the eQMS system.
• Assist in document management activities such as creating and updating procedures, process flow diagrams and work instructions. Oversight into the overall change management process.
• Interact with other departments to develop and maintain a compliant quality system using industry best practices as a foundation.
• Perform other related duties as necessary to meet the ongoing needs of the organization.
• Update, develop SOPs and ensure timely implementation of the SOPs in the eQMS system.
• Lead the Corrective and Preventive Action activities.
• Monitoring and measurement of Key Performance Indicators for QMS processes.
• Identify compliance gaps and develop plans to address those gaps.
• Lead and support Quality System Improvement Projects.

Quality Requirements: 
NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices, and employees of NDI. Our goal is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional
Education and Professional Qualifications:

• 5+ years of related experience in quality.
• ISO 13485:2016 Internal Auditor Certification.
• Undergraduate Degree.

Desired Characteristics/Additional Assets:

• Previous exposure to quality principles and tools in the medical devices industry.
• Excellent attention to detail and organization skills.
• Excellent verbal and written communication skills.
• Experience with data process and statistical analysis.
• Must be able to effectively communicate with many levels across Engineering, Quality, Sales and Marketing, and Manufacturing.
• Academic background in sciences, engineering, or mathematics.
• Ability to work independently.

Why Choose NDI:

• Employee social and engagement events throughout the year.
• Starting at 3 weeks’ vacation plus a company-wide Holiday shut-down in December.
• Subsidized professional development and training opportunities.
• Generous employer-paid benefits package.
• A Waterloo Region 2023 Top Employer.
• Company-wide bonus program and annual salary reviews.
• Close to GRT and ION stops with free on-site parking.
• Growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
• Employee stock purchase plan.
• Competitive salary with a Registered Retirement Savings Plan match of up to 4%.
• It is common in many positions to work in a hybrid model, where flexibility and autonomy are supported by a combination of remote and in-office work.  

Being a Part of our Team:
When you walk through our doors, you will find an open-concept office that promotes collaborative teamwork and fresh ideas. We enjoy tackling new challenges and developing new pathways to serve our customers. We are looking for innovative, hard-working individuals who don’t see this as just a job, but as a career choice. If this sounds like you, our HR team would love to hear from you. Follow the instructions below to submit your application.
We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.