SHOEBOX is hiring a
Quality Assurance Associate, Canada

Summary

The job is for a Quality Assurance Associate at SHOEBOX, a hearing aid company under WS Audiology Group. The role involves maintaining compliance with regulatory requirements, managing quality assurance processes, auditing, investigating customer complaints, and generating reports. The candidate should have a post-secondary degree and 1-2 years of experience in Quality Assurance.

Requirements

• Post-secondary degree in science, engineering, business or equivalent
• 1-2 years of experience in a Quality Assurance Role in medical devices/pharma or other regulated industry
• Experience running core Quality processes including Corrective and Preventive Actions, Non-conformances, Document Control
• Solid understanding of Quality Management concepts
• In-depth knowledge of all relevant Quality Management Standards including ISO 13485:2016, ISO 14971:2012, 21 CFR 820, EU MDR, Health Canada Regulations
• Excellent analytical and problem solving skills
• Self-motivated, detail-oriented, responsible and timely team-player
• Excellent written, verbal, presentation and collaboration skills
• Comfortable in a fast-paced, high energy, customer-focused start-up environment

Responsibilities

• Assist in maintaining compliance of ISO 13485 Quality Management System (QMS) to US FDA, Health Canada, European MDD and other global regulatory requirements
• Ensure effective implementation of QMS processes
• Work with process owners to facilitate effective process execution and continuous improvement efforts
• Manage key quality assurance processes: document control, records control, non-conforming material, corrective and preventive action, etc
• Audits; Assist QA Manager in internal audit program and external audits and inspections
• Investigate customer complaints and product returns
• Assist in managing new and existing product and site regulatory registrations
• Inspect received material and outgoing customer orders
• Analyze quality data and generate reports
• Support sales efforts by providing regulatory and quality data as required
• Contribute to many different areas of this exciting homegrown Ottawa business
• Generate reports as required by company SOPs and regulatory requirements
• Other duties as assigned

Preferred Qualifications

• Familiar with process improvement concepts such as DMAIC
• Prior experience in statistical methods and the use of statistical software such as SAS JMP, Minitab, R
• Prior experience working in a SaMD manufacturing environment operating using Agile development methodology

Benefits

• Competitive salaries and benefits
• Real work-life balance
• Flexible hours
• A discretionary wellness benefit
• SHOEBOX will provide you with a MacBook Air with memory to spare