About Orpyx

Orpyx is a leading digital therapeutics company that is committed to extending healthspan for people living with diabetes through personalized remote care. Our flagship product, the Orpyx SI Sensory Insoles, is transforming diabetes care by helping prevent diabetic foot ulcers, a major complication of diabetes that can lead to amputation. Our dedicated remote patient monitoring team, comprised of credentialed providers and nurses, utilizes advanced data science methodologies to provide personalized support and triaged clinical escalation. With our whole-person approach, Orpyx empowers people to take control of their health, prevent debilitating complications and extend their healthspan. We are an ISO 13485 company committed to providing quality medical solutions that consistently meet customer needs and regulatory requirements.

Who we are

The people at Orpyx are flexible thinkers and creative innovators. We come from a variety of backgrounds and carry a wealth of expertise in multiple industries, including medical, technology, software, marketing, and finance. What we all have in common is an intense passion for the work we do. We have an extraordinary collection of talent that makes working here fun, unique and inspiring. Our hiring goal moving forward is to continue to build and grow a strong, effective team, while maintaining our friendly and innovative company culture.

What we offer

We offer an opportunity to work with cutting-edge medical technology that extends the healthspan of people living with diabetes. We offer a competitive salary and a comprehensive benefits package that includes medical, dental, and health or wellness spending account. Our flexible health benefits, RRSP matching program, and employee stock option plans allow for customized benefits that meet your individual needs. In addition, our employees receive 4 weeks vacation to start and paid flex and health days, giving them ample opportunity to rest and recharge. We have team events every second Friday, and annual in-person events, which contribute to a positive work culture and foster team connections

What you'll do

Reporting to the Quality Manager and working as part of a cross-functional team, the Senior Quality Associate is responsible for ensuring that our products meet the highest quality standards and comply with the relevant medical device regulations. The successful candidate is responsible for ensuring the organization maintains an effective quality management system that meets ISO 13485 and applicable regulatory requirements. The Senior Quality Associate will be appointed the quality management representative with the associated responsibilities and authorities to ensure effective operation of the Quality Management System (QMS).

This includes:

Quality Assurance Management (QA)

• Maintains the QMS (Quality Management System) to ensure ongoing compliance with ISO 13485, US FDA Title 21 CFR 820, Health Canada Canadian Medical Device Regulations (CMDR) and other requirements, as required.
• Supports and instills a culture of quality within Orpyx
• Ensures effective document control and record-keeping in line with QMS requirements
• Monitors and reports on the effectiveness of the Orpyx QMS
• Attends weekly quality meetings, including setting the agenda, monitoring the status and progress of key issues, actions and commitments and keeping the Quality Manager informed of key updates
• Manages and maintains the CAPA (Corrective and Preventive Action) program, non-conformances, and deviations to ensure continuous improvement
• Supports risk management activities in compliance with ISO 14971
• Supports and maintains QMS policies and processes to ensure product quality and compliance with industry standards
• Supports and maintains quality control processes throughout the product lifecycle, from design and development to manufacturing and distribution
• Supports the communication and resolution of quality management issues within Orpyx
• Work with cross-functional teams to address quality issues
• Drives the development of an annual compliance schedule in coordination with internal groups
• Stay abreast of relevant regulations, standards, and guidelines applicable to the medical device and healthcare industry
• Manages and oversees the preparation for and participation in internal and vendor audits
• Establishes, executes, and reports on internal audit program and follows up on action items
• Fosters a culture of continuous improvement and identify opportunities for training and development with respect to quality management and the QMS
• Develop content and support employee training on quality processes, standards, and compliance

Regulatory Affairs Support

• Drafts, under the direction of the executive, regulatory documents for executive to review, and health authorities and regulatory agencies
• Supports the preparation and submission of regulatory filings (e.g., 510(k), CE Marking, MDR submissions, Health Canada, etc.).

General

• Prepares reports for management
• Maintains a clean, and safe working environment
• Performs duties in a manner that is consistent with and committed to upholding the requirements of the quality management system

Additionally, due to the ever-changing and sometimes chaotic environment of an early-stage high-tech company, the Senior Quality Associate may assume additional responsibilities, as required

What youll bring

• Post-Secondary degree in Business, Engineering, or a related field
• Certified ISO 13485 Internal Auditor or willingness to become one
• Completed training on current ISO 13485:2016 standard or similar ISO standard
• 3+ years of experience working in a medical device/equipment manufacturing industry
• Experience with eQMS software considered an asset
• Demonstrated knowledge and experience managing Quality Management systems
• Demonstrated knowledge of MDSAP, ISO 13485, ISO14971, Health Canada and FDA Title 21 regulations
• Excellent attention to detail, critical thinking, and analytical abilities
• Demonstrated decision-making and problem-solving skills
• Demonstrated ability to own and influence project and key results in a fast-paced environment
• Excellent communication and interpersonal skills, with a demonstrated ability to influence, interact and work effectively with key internal and external stakeholders
• Ability to identify potential problems and take appropriate action
• Very strong time management and organizational skills with the ability to prioritize and manage own workload whilst multi-tasking in order to meet deadlines
• Must thrive in a start-up, fast-paced, ever-changing work environment and be comfortable navigating the grey

The details

Application instructions and deadline: Please submit a cover letter and resume that outlines why your skills, experience and personality would make you an excellent candidate for this role at Orpyx by 5pm on August 29, 2025.

Employment status: Permanent full time.

Schedule:
40 hours per week from Monday to Friday. Peaks and valleys may be required periodically, depending on operational needs.This role is not overtime eligible.

Work location: Calgary, Alberta.Please note that this position is required to work onsite at our Head Office located at Suite 205, 1240 20thAvenue S.E.

For more information, visit:
https://www.orpyx.com