Quality Assurance Associate
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 who 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:
- 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
- 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
- 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.
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.
We invite enthusiastic and qualified applicants to submit their resume by email firstname.lastname@example.org. Please include “Quality Assurance Associate” in the subject line.
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.