For the Quality/Engineer Specialist position, Sonoscope is looking for a highly motivated and investigative QA specialist / engineer who is willing to grow professionally in a startup setting.
Reporting to the Director of QA/RA & Research, the selected candidate will work with collaborative team members to perform Quality Engineering functions in support of projects associated with design development, risk management, requirements, implementation, verification, drive to quality improvements and conformance to standards and regulations. The incumbent will also lead the documentation effort for our medical device software and hardware, primarily complying with a 510(k) FDA registration (and corresponding CE Mark registration).
- Review and revise quality documents: procedures, work instructions and forms.
- Assist with the design & development process of medical devices (risk management, design control, requirements definition, verification, design reviews and design change).
- Interact daily and work closely with hardware and software engineers to understand the engineers’ system specification, requirements and product design.
- Ensure the adequacy of system design quality through design and documentation control.
- Perform process validation on new and current manufacturing processes.
- Investigate root cause of nonconforming products and determine disposition.
- Support suppliers’ evaluation activities.
- Support post-market surveillance activities.
- Lead the training of team members on procedures.
- Collaborate with external departments.
- Assist with the design and creation of customer-facing documentation including quick start documentation, user manuals and troubleshooting guides.
- Perform internal audits.
- Holds a Bachelor of Science Degree, a BS degree in Engineering, Math or Computer Science, or equivalent and combined; MS degree in Engineering or Computer Science, preferred.
- Possesses a minimum of 5 years of experience in a medical device manufacturing environment preferably with software related products.
- Is familiar with the medical device requirements for commercialization in USA, Canada and Europe markets (minimally ISO 13485, ISO 14971 and IEC 62304; IEC 62366 and IEC 60601 is an asset).
- Is familiar with electronic quality management system and documentation tools such as Qualio, Confluence and JIRA, an asset.
- Internal auditing and risk management experience, an asset.
- Is proficient in written and spoken English; Proficient in spoken French, an asset.
- Ability to work and adapt in a fast-paced environment.
- Worked in a cloud-based environment, an asset .
PROFILE SOUGHT :
- Excellent communication skills, both written and oral; computer literate.
- Ability to work in groups as well as independently with minimal supervision.
- Strong analytical and problem-solving skills are essential.
- Strong work ethic and integrity.
- Highly motivated to understand software/hardware systems.
- Ability to speak with engineers as needed in order to expand that understanding for documentation purposes.
- Comfortable with various levels of documentation, ranging from procedures to low level requirements.
- Proven ability to deliver presentations and training, effectively and efficiently with clear communication skills and delivery.
- Experience doing technical writing and editing, a plus.
- Experience as an internal auditor, a plus.
- Technical knowledge of basic programming experience, a plus.
WE OFFER :
- A permanent, full-time position.
- A competitive base salary.
- Flexible working hours.
- A warm, relaxed and stimulating work environment.
- A telework policy that meets your needs.
- Proximity to downtown and easy access to public transportation.
- Numerous opportunities for professional development.
- A multidisciplinary and diversified team, led by international leaders in emergency and resuscitation medicine.
- A company propelled by Centech, one of the most successful business incubators in North America.
Send your resume now to: firstname.lastname@example.org or spread the word!
Looking forward to meeting you!