Quality Assurance Associate

3 weeks ago

Ottawa, Canada SHOEBOX Audiometry Full time

***
**Job Location: Hybrid/Ottawa, ON**

**About the job**:
**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.

**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

**Qualifications**:

- 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

**Assets**:

- 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?** WS Audiology (WSA) is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations.

SHOEBOX is part of the WS Audiology Group (WSA), a global leader in hearing care with the ambition of making wonderful sound part of everyone’s life.

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.

To learn more about us and what we stand for, check out our story and blog.

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 resumes here.

We thank all applicants; however, only those selected for an interview will be contacted.

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