Senior Quality Engineer | QW982

Senior Quality Engineer | QW982

21 Mar
Baylis Medical

21 Mar

Baylis Medical



Our team is growing and we are currently looking for a Senior Quality Engineer to join our team.The Senior Quality Engineer participates in continuous improvement activities in an cross-functional engineering team and resolves issues with manufacturing processes and supplier materials for their assigned product line. Tracks data, identifies improvement projects and manages cross-functional implementations to improve the performance of the quality system and the production line. This position requires leadership skills that would enable the Senior QE to drive major Quality improvement projects across functions.

Snapshot of Responsibilities

Provides Quality Engineering support for manufacturing.

Investigates non-conformances and implement corrective and preventive actions in place.

Facilitates CAPA and ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Applies knowledge of design control principles, statistics, process validation and quality engineering techniques to positively influence production.

Reviews process changes and ensures the changes are in accordance with regulatory requirements and customer requirements.

Utilizes quality tools including Risk analysis (FMEA), applies statistical techniques including six-sigma and DOE (design of experiments), reviews and correct drawings.

Navigates government regulations including FDA requirements and guidance under 21 CFR 820, ISO 13485 and ISO 14971.

Present technical data to groups within and outside the organization.

Develops, modifies, and maintains quality standards and protocols.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Review of manufacturing procedure and ensures methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment are in place.

Provides guidance to other staffs in the team to work on common projects.

What you bring to the team:

Bachelor's degree in engineering required.

4-5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience.

Must be a critical thinker and active listener with good time management skills.

Self-starter with the ability to quickly learn about new processes.

Excellent analytical and communication skills (written and oral).

Ability to work effectively within team and across functions.

What we have to offer:

Smart commute options including complimentary shuttle from Kipling Station, and subsidized transit program.

Flexible working hours that complement core business hours.

One day off for volunteering, to give back to a charitable organization of your choice.

Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.

Comprehensive total rewards package, including tuition reimbursement and lifestyle and health spending account.

Well-being initiatives, including onsite gym facility and fitness classes (yoga and boot camp).

Employee-friendly work environment, with opportunity to participate in employee-led clubs, organized sports teams, video games, foosball, ping pong, etc.

Nice to have:

Knowledge on various engineering principles including laser welding, molding, sterilization and biocompatibility.

Lean Six Sigma certification.

Medical device experience; or experience in a regulated environment

About Us

At Baylis Medical, everyone works with a shared purpose: to improve the lives of people around the world. Named one of Canada's Best Managed Companies, we are a rapidly growing leader in the development, manufacturing and commercialization of innovative medical devices in the field of cardiology. Our focus is on providing physicians clinically-relevant tools, so that no patient goes untreated.

We are looking for talented individuals, like yourself, to join Baylis Medical and make an impact in the lives of patients. Are you ready to join us?

Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process

While we thank all applicants, only those being considered for an interview will be contacted.

Want an inside look at careers and life at Baylis? View employee profiles on The Muse and follow us on Instagram @Baylismedical

The original job offer can be found in Kit Job:

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