Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.
If you share our values and want to work in a collaborative results-focused culture and want to make a profound impact in healthcare and your career, here is your chance.
General Accountability
The Quality Engineer is responsible for overseeing Quality Improvements across Manufacturing and R&D to ensure product quality and consistency, improve efficiency, and drive value throughout the business.
Quality Engineer helps to identify areas of improvement and ensure compliance to the Profound QMS, relevant regulations and standards.
Duties and Responsibilities
- Contribute to a positive work culture and foster a high-performance team environment.
- Collaborate with stakeholders across departments to identify areas of improvement and implement quality improvements.
- Investigate Complaints, Returned products & Non- Conformities
- Improve In-Process and Incoming Inspection testing
- Work with the Manufacturing & Operations teams to improve the Capital Equipment and Disposables lines.
- Identify opportunities for tools, fixtures & process improvements.
- Work with stakeholders to create and deploy fixtures & tooling.
- Understand current QMS processes and implement procedure improvements to expedite projects and improve compliance.
- Manage product requirements and ensure traceability.
- Participate in risk management activities, including the identification and mitigation of potential quality risks.
- Ensure processes are set up to encourage adherence to QMS.
- Travel as required to support business activities.
- Other duties as assigned.
Education
University degree in Engineering or Science; or relevant work experience
Certifications
P. Eng is an asset
Key Attributes
- 5+ years of experience working in a regulated industry (medical, automotive, aerospace, etc.)
- Experience working in a clean room.
- Proven examples of fixture/tool implementation projects which deliver meaningful results to the business.
- Experience working on projects in a regulated environment; medical device development experience is an asset.
- Experience transferring designs from engineering to manufacturing
- Experience operating in a quality environment such as GLP, GMP, GCP, ISO 13485 or equivalent
- Able to work well in teams and independently
- Detail-oriented; highly motivated; patient and diligent
- Excellent problem-solving skills
- Clear, concise and thorough documentation
- Excellent verbal and written communication skills
- Valid passport for travel to United States and Europe.
We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.
The expected base salary range for this role is $90,000 - $100,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.
We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.
