Product Quality Engineering Specialist

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 a member of the Quality Assurance team, the Product Quality Engineering Specialist supports the development of NDI products and leads investigations into product failures. This individual has an in-depth understanding of NDI product requirements and quality processes. They work closely with product development, purchasing, manufacturing, and customer experience teams to complete product failure investigations and support product and process improvements and remediations. They support and act as the primary liaison for periodic inspections by test laboratories. Additionally, this individual supports risk management activities and new product development initiatives. They have excellent expertise in electro-mechanical systems, including a strong working knowledge of assembly and IPC standards. They utilize experience with Fault Tree and FMEA tools to conduct root cause analyses.

Scope of Responsibilities:

• Support the development and deployment of product reliability and verification activities.
• Develop and implement supplier quality standards and requirements.
• Conduct technical reviews of electronic designs.
• Perform root cause analysis of component failures to identify process improvements to prevent recurrence.
• Collaborate with suppliers to resolve quality issues and implement corrective actions.
• Act as primary liaison for audits and inspections by electrical safety testing organizations.
• Manage supplier quality with key supplier performance data to ensure minimum disturbance to the manufacturing process.
• Support projects aimed at enhancing the value-added supply chain.
• Ensure compliance with industry standards (ISO13485, FDA QMSR, EU MDR, etc.)
• Support the selection of new suppliers as driven by product development activities at NDI.
• Participate in the NDI internal auditor program.

Quality Requirements:

NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices, and employees of NDI. Our objective 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 regulatory requirements of the markets in which our products are sold. Employees of NDI are instrumental to our compliance efforts and are required to understand and comply with the QMS.

The Product Quality Engineering Specialist is connected to the NDI Quality Management System in several ways as defined below.

Proficiency:

• Extensive knowledge of electro-mechanical products including understanding technical requirements and manufacturing processes for PCB’s.
• Extensive knowledge of production causes of product failures and the process for correcting or improving processes.
• Profound understanding of quality principles and apply them effectively and efficiently to quality improvements in all product-related fields.

Competency:

• Conducts root cause analyses and identifies appropriate corrective/preventive action plans for supplier-provided components.
• Understands requirements of ISO 9001, ISO 13485, and the FDA Quality System Regulation.
• Understands the non-conformance, corrective/preventive action, and supplier management processes.

Education and Professional Qualifications:

• College diploma in an engineering, electrical technician, or equivalent experience.
• Knowledge of APQP, PPAP, FAI, and supplier audits.
• Minimum 5 years’ experience as a Quality Engineer or Supplier Quality Engineer.
• Minimum 5 years’ experience with electro-mechanical assembly techniques.
• Minimum 5 years’ experience in quality assurance activities such as inspection, supplier management, and root cause analysis.

Desired Characteristics/Additional Assets:

• Passion for quality improvement and continuous development.
• Strong communication skills and collaborative team player.
• Proficient in both written and oral communication.
• Proactive problem solver who utilizes quality metrics to drive improvements.

Why Choose NDI:

• Generous employer-paid benefits package.
• Company-wide bonus program and annual salary reviews.
• Competitive salary with a Registered Retirement Savings Plan match of up to 4%.
• Employee stock purchase plan.
• 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.
• Starting at 3 weeks’ vacation plus a company-wide Holiday shut-down in December.
• Employee social and engagement events throughout the year.
• Subsidized professional development and training opportunities.
• A Waterloo Region 2025 Top Employer.
• Growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
• Close to GRT and ION stops with free on-site parking.

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.