The Quality Systems Analyst will join a fast growing medical technology company in a position that supports design, production and process quality. You will contribute to the maintenance of the quality system ensuring compliance to industry standards and regulatory requirements. You will also ensure that products are safe and effective.
As a snapshot, we are looking for someone who:
- Possesses quality management experience in a regulated working environment
- Is able to take a problem, identify the root cause and develop a solution
- Promotes a culture of quality
Job Duties and Responsibilities
- Review, analyze and report on quality issues and propose disposition and corrective actions for recurring discrepancies
- Support QA activities related to audits, training, change control, document and record management
- Prepare periodic reports to support the Quality Management System
- Analyze sources of quality data to identify problem trends and opportunities for improvement
- Assist in the maintenance, approval and creation of quality documentation
- Represent quality in product development initiatives (e.g. New Product Development, Verification/Validation, Sustaining Engineering, etc.)
Required Skills and Experience
Skills and Experience to Enable Success:
- Degree in Engineering, Science or related disciplines
- Post-Graduate diploma in Quality Assurance is an asset
- 3+ years of relevant quality management experience in a regulated industry
- Understanding of US, Canada and International Medical Device Regulations
- Working knowledge of root cause analysis tools
- Experience working in a medical device or technology environment
- Immense attention to detail – you work in quality after all!
Expectations and Employee Experience
- We do not expect to hire someone who fits the position 100%
- We expect that you will be passionate about growth and you can expect that we will support you along the way
- You can expect to work hard but know that you will be rewarded for that hard work
- You can expect change within our growing company
- You can expect that we help you be you!
- Flexibility so that you can do your best both at work and outside of it
- Relaxed yet professional workplace that encourages inclusivity
- An understanding of how your performance is measured
- Culture = Passion: we have a ton of passion for the product, improving patients’ lives and working collaboratively to achieve common goals
- Oh ya, some amazing social events too! These will be formal, informal, scheduled and pop up out of no where. Be prepared, we like to work hard but have some fun too!
If you aren’t happy about these expectations, we may not be the company for you. If you are happy, great! We would love to hear from you!
The Journey, Mission and Future of Intellijoint
- What we are doing is “improving patients’ lives by providing every surgeon with effective, easy-to-use technology.”
- Born out of a University of Waterloo final year design project, our product improves the accuracy of hip replacements
- In a nutshell, Intellijoint HIP® provides surgeons with real-time, interoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty.
- Already, our product is being used in thousands of surgeries that spread throughout the United States, Canada and Australia and we will continue to look at expansion into other areas.
To apply, please visit our job board. This is a full time, permanent position based at Intellijoint Surgical’s main office in Kitchener, Ontario, Canada. Please submit cover letter and resume for consideration. Only selected applicants will be contacted for an interview. Thank you!