Job Type: Full-time
Job Location: Ottawa, ON
We’re looking for a confident, proactive candidate to join our team and contribute to our quality and compliance initiatives. You will work with people across the organization to help SHOEBOX continuously improve our medical device product and service offerings to customers. This is an opportunity to make a real impact on the world by furthering our mission to expand hearing healthcare around the Globe with our innovative mobile and web-based medical solutions, and to work with an amazing (seriously, amazing) group of brilliant and passionate people.
Why we need you:
You are a dedicated, collaborative Quality Assurance team member who is looking for an opportunity to make an impact on a team that thrives on change, process, and product improvement, and moves quickly.
We are growing really fast, and we need a strategic cross-team collaborator to inform, enable, and contribute to team efforts while ensuring consistent compliance with regulatory requirements and medical device quality standards. You love detail-oriented work, working with others to solve problems and thrive in a fast-paced, constantly changing environment. You are a collaborative team player, and a happy do-er, and are committed to developing your subject matter expertise.
Your primary responsibilities:
- Ensure effective implementation of QMS processes by monitoring QA systems and advising QA leadership on system performance
- provide status reports of quality activities
- Create and maintain QA control documentation, analyze data, and generate reports as required by company SOPs and regulatory requirements
- Assist with document control, records control, non-conforming material, corrective and preventive action, investigating complaints, and more
- Work with process owners to facilitate effective processes and continuous improvement
- Audits; Assist QA Manager in internal audit program and external audits and inspections
- Assisting the QA Manager with administrative functions and processes
- Ensuring project team adheres to provided timelines and deliverables
- Communicating plans, actions, risks, and issues with key stakeholders
- Create and review technical documentation, including project plans, test procedures, and design documents.
- Develop, review, and maintain metrics and quality audits.
- Ensures quality and accuracy in day-to-day activities
- Contribute to many different areas of this exciting homegrown Ottawa business.
- Other related duties as required or assigned.
- Post-secondary degree/diploma (or a combination of related education and experience of at least 3 years)
- 3-6 years of related industry experience, preferably in a regulated environment
- 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
- Knowledge of Google Office and Microsoft Office productivity suites.
- Knowledge of working with Software Development
- Excellent analytical and problem-solving skills
- Attention to detail and ability to maintain up to date and accurate records
- Excellent written, verbal, presentation, and collaboration skills
- Capable of working well individually as well as part of a team
- Strong work ethic and positive team attitude.
- Comfortable in a fast-paced, high energy, customer-focused start-up environment
- It is a mandatory condition of your employment that: (i) you are vaccinated for COVID-19 with vaccines that have been approved by the Government of Canada; (ii) you have received both of your vaccines at least 14 days prior to your start date; and, (iii) you receive any recommended COVID-19 related boosters which are subsequently approved and recommended by the Government of Canada. Note: If you are unable to receive COVID-19 vaccines due to medical or human rights reasons, please let us know so that we can discuss potential accommodations.
- Prior experience working in a SaMD manufacturing environment using Agile development methodology.
Who are we? We’re SHOEBOX Ltd. We design and develop audiometry products that are creating a seismic shift in the way hearing healthcare is provided. Utilizing iOS and web technology to replace bulky, expensive equipment, we’re bringing hearing testing into the 21st century and making it more affordable and accessible than ever before.
Why that’s important: 5% of the world’s population suffers from disabling hearing loss, 60% of childhood hearing loss is due to preventable causes, and the majority of people with disabling hearing loss live in low-middle income countries. We can help. With our products, hearing testing can be conducted outside of a sound booth and without the need for clunky equipment (you just need a calibrated headset and an iPad), which allows for testing almost anywhere, anytime, worldwide.
At SHOEBOX, your contribution will have a meaningful impact every single day. On top of that, you’ll be an integral part of an innovative team, working with the latest tools and technologies, pushing the boundaries of what the Quality Assurance function can do, and collaborating with colleagues who are super passionate about their crafts.
In joining us, you’re joining a dedicated and passionate team that works hard and cares deeply about the change we’re making in the world. We also take time to celebrate our successes, enjoy lunchtimes together, and genuinely like and care about one another. Also, our founder knows how to do magic tricks. It’s pretty cool.
We offer competitive salaries and benefits, real work-life balance, flexible hours, and a discretionary wellness benefit. SHOEBOX will provide you with a MacBook Air with memory to spare.
Location of work: As a result of the pandemic, SHOEBOX has moved to a “collaboration first” model, which means that most employees currently work from home and, as the office re-opens, this role will work some combination of work from home and at the office. All in-office work and in-person meetings for work that take place outside of the office will be subject to SHOEBOX’s Vaccination Policy, as well as its health and safety procedures. These policies and procedures will require, among other things, full vaccination against COVID-19 as a condition of going into the office or having meetings for work outside of the office.
We invite enthusiastic and qualified candidates to APPLY HERE
We thank all applicants; however, only those selected for an interview will be contacted.
SHOEBOX is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We welcome and encourage applications from people with disabilities. Accommodations are available.