Manufacturing Technician, Quality Inspection

**About Orpyx Medical Technologies Inc.**

Orpyx develops digital therapeutics to extend mobility and healthspan for people living with diabetes. We are an ISO 13485 company committed to providing quality medical solutions that consistently meet customer needs and regulatory requirements. Orpyx® SI Sensory Insole System is comprised of sensor-embedded shoe insoles used to empower people with diabetes to extend mobility by preventing diabetes-related complications such as foot ulcers and amputation. The sensory insoles send feedback to an app-based display. The sensory data is uploaded to the Orpyx SI cloud-based dashboard, where the data can be monitored between care visits by our credentialed care team. Our business model is a combination of medical device sales and SaaS (software-as-a-service) and meets the requirements for HCPCS and CPT reimbursement.

**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.

**The Position**

Reporting to the Production Manager and working as part of a cross-functional team, the Manufacturing Technician, Quality Control is responsible for administrative duties in manufacturing including data entry, phone provisioning, and performing calibration, characterization activities to support the production environment.

This includes:

- Utilize manufacturing software - MES to control workflow and record work progress
- Maintaining accurate and timely quality documentation including Standard Operating Procedures, work instructions and quality records
- Identify and report product and equipment inconsistencies to the Production Manager
- Identify and communicate production status, issues, deviations or bottlenecks and general information and escalate issues to Production Manager, as required
- Complete incoming quality inspection on parts and products
- Provision parts and products to the appropriate end-user in Orpyx systems (admin dashboard)
- Configure software and firmware on parts, subassemblies, and products (digital displays & insoles)
- Create and print product labels for products the company manufactures and distributes
- Review production orders for accuracy and completeness for release to shipping
- Entering and updating confidential customer and order information
- Adhering to all company policies/procedures and regulatory compliance procedures
- Assist with cross-training other members of the production team in areas of competence
- Performing other related tasks as assigned, including logistics and shipping support, as required
- Assist members of the production team with quality assurance related documentations
- Liaise with Production Manager, engineers, and others to meet requirements of schedule, quality, and safety
- Maintaining accurate and timely quality documentation including Standard Operating Procedures, work instructions and quality records
- Timely and accurate data entry as required
- Support operational initiatives (for example the 5s initiative) by completing administrative tasks including but not limited to inventory, stocking stations, organizing workstations etc.
- Follow Personal Health Information regulations where applicable
- Work in compliance with ESD (electrostatic discharge) guidelines
- Perform other manufacturing related tasks, as assigned
- Maintain a clean, and safe working environment
- Perform 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 Manufacturing Technician, Quality Inspection may assume additional responsibilities, as required.

**Qualifications**
- High school diploma is required, however, we will consider relevant experience a substitute in some cases
- Some post-secondary education or bachelor’s degree or equivalent considered an asset
- 1+ years of relevant production experience is required
- Demonstrated experience with quality assurance processes
- Demonstrated ability to follow instructions precisely with the ability to carry out daily work instructions
- Demonstrated experience using hand and power tools
- Experience with medical devices, wearable technologies, sensor-related technologies is highly valued
- Experience working in an ISO 13485 environment is considered an asset
- Able to identify and assist in resolving problems in a timely manner
- Demonstrated computer and data entry skills and experience
- Punctuality and reliability a