Quality Manager – SHOEBOX Audiometry
We believe that everyone deserves access to hearing healthcare. We’re looking for an energetic candidate to join our team to manage all of our quality and compliance initiatives. This is your opportunity to have a direct impact on addressing a global health issue and to join an exciting business where we thrive on changing paradigms, trying new things (and learning from them every time), and moving quickly.
We’re SHOEBOX Audiometry, a division of Clearwater Clinical. We are combining medical, technical, and entrepreneurial expertise to lead transformation in the way hearing healthcare is provided. Utilizing iOS and web technology to replace bulky, expensive equipment, we are making hearing testing more affordable and accessible than ever before with SHOEBOX Audiometry, the world’s first easy-to-use, automated, iPad audiometer.
With our products, hearing testing can be conducted outside of a sound booth and without the need for clunky equipment, and data can be analyzed remotely, which allows for testing and analysis almost anywhere, anytime, worldwide.
This means that at SHOEBOX, your contribution will have a truly meaningful impact every single day.
Why we need you:
We are growing really fast, and we need more passionate, dedicated, awesome people to join our team and help us make a difference.
What you will do:
- Maintain compliance of ISO 13485 Quality Management System (QMS) to US FDA, Health Canada, European MDD and other global regulatory requirements.
- Act as Management Representative for the QMS, leading management review process to ensure effective implementation of QMS.
- Work with process owners to establish and monitor a Quality Objectives Scorecard to assess organizational performance and focus continuous improvement efforts.
- Manage key quality assurance processes: risk management, document control, records control, non-conforming material, corrective and preventive action, equipment calibration, etc.
- Work with Development to ensure agile development process meets design and development and risk management requirements.
- Audits; manage internal audit program and external audits and inspections.
- Services quality assurance; work with post-Sales functions to ensure services delivered to customers consistently meet their expectations.
- Investigate customer complaints and product returns.
- Provide training to employees on aspects of the QMS that are relevant to their role.
- Manage new and existing product and site regulatory registrations.
- Gather, analyze and present regulatory intelligence on target markets and recommend regulatory strategy.
- Review and approve product labeling for compliance.
- Manage other compliance programs as required (i.e. HIPAA).
- Contribute to many different areas of this exciting homegrown Ottawa business.
- Other duties as assigned.
- You have an undergraduate degree in science, engineering, business or equivalent combination of relevant job experience, training and knowledge.
- You have a minimum of 5 years experience in a Quality Management role, preferably in a medical device and software environment.
- You have demonstrated success in leading continuous improvement initiatives to achieve tangible business results.
- You have excellent analytical and problem-solving skills.
- You are a certified ISO 13485 or ISO 9001 internal auditor.
- You are effective in communicating and collaborating with all levels of the business ranging from the organization’s executives, developers, support, and sales.
- You are a self-motivated, detail oriented, responsible and timely team-player with excellent written, verbal, presentation and collaboration skills.
- You are comfortable in a fast-paced, high energy, customer-focused start-up environment.
Job Type: Full-time
Job Location: Ottawa, ON
We offer competitive salaries and benefits, flexible hours, stock options and a discretionary wellness benefit.
How to Apply?
We invite enthusiastic and qualified applicants to submit their resume by email firstname.lastname@example.org. Please include “Quality Manager” in the subject line.
We thank all applicants; however, only those selected for an interview will be contacted.
(Clearwater Clinical/SHOEBOX Audiometry has an accommodation process in place and provides accommodations for applicants with disabilities. If you have specific ergonomic needs or require other accommodation because of a disability or a medical need, please contact Clearwater at 613-728-6666 to discuss arrangements.)
We’re SHOEBOX Audiometry. We design and develop products that are creating a seismic shift in the way hearing healthcare is provided. By replacing slow and expensive traditional approaches with mobile technology, we’re bringing healthcare products in the Audiology industry into the 21st century—making them easier to use, more affordable, and better than ever before.
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 (often with beer, though sometimes with cookies), enjoy lunchtimes together, and genuinely like and care about one another. Also, our founder knows how to do magic tricks. It’s pretty cool.