Quality Engineer Iii

At Baylis Medical Technologies, we develop innovative medical devices that improve patient care and enhance lives around the world. Quality is at the core of everything we do.
As a Quality Engineer III, you will play an important role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance throughout the product lifecycle. This is a fully proficient engineering role where you will independently manage quality engineering activities, contribute to complex projects, and partner with cross-functional teams to solve technical and quality challenges.
Working closely with R&D, Manufacturing, Regulatory Affairs, Operations, Supply Chain, and external partners, you will provide quality engineering with a primary focus on day-to-day manufacturing and product support, continuous improvement projects, and design changes, and help ensure products and processes continue to meet applicable quality, safety, and regulatory requirements.
Your Impact Through Innovation
Independently manage quality engineering activities and deliverables supporting manufacturing, validation, and lifecycle management initiatives.
Provide quality engineering support for design and engineering changes by assessing quality and regulatory impact, updating risk and quality documentation, and confirming appropriate verification or validation activities.
Own or support nonconformance reports (NCRs), including containment, investigation, root cause analysis, risk evaluation, disposition, implementation of corrective actions, and effectiveness follow-up.
Lead and support continuous improvement projects by analyzing quality and process data, identifying opportunities, evaluating risk, and implementing sustainable improvements
Review and approve applicable Quality Management System documents and quality records within the role's area of expertise.
Plan and prioritize assigned work independently, participate in project-level planning, and provide technical guidance to cross-functional engineers and stakeholders at all levels, as appropriate.
Support continuous improvement projects by analyzing quality and process data, identifying opportunities, evaluating risk, and implementing sustainable improvements.
Develop and execute verification and validation protocols, including data analysis, statistical rationale, sample size justification, and documentation.
Participate in and lead investigations using structured problem-solving methodologies such as 5 Why, Fishbone, and Fault Tree Analysis.
Identify quality and compliance gaps and contribute to corrective and preventive actions that improve product and process performance.
Analyze quality data and trends to identify improvement opportunities and reduce risk.
Conduct supplier audits and internal audits, and participate in customer and regulatory audits, including audit preparation, documentation review, execution, and follow-up activities.
Partner with suppliers and internal stakeholders to address quality concerns and drive continuous improvement.
Support method validation, equipment qualification, process validation, and manufacturing quality initiatives.
Contribute to a culture of accountability, continuous improvement, and operational excellence.
The Big PictureAt Baylis Medical Technologies, we develop innovative medical devices that improve patient care and enhance lives around the world. Quality is at the core of everything we do.
As a Quality Engineer III, you will play an important role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance throughout the product lifecycle. This is a fully proficient engineering role where you will independently manage quality engineering activities, contribute to complex projects, and partner with cross-functional teams to solve technical and quality challenges.
Working closely with R&D, Manufacturing, Regulatory Affairs, Operations, Supply Chain, and external partners, you will provide quality engineering with a primary focus on day-to-day manufacturing and product support, continuous improvement projects, and design changes, and help ensure products and processes continue to meet applicable quality, safety, and regulatory requirements.
Your Impact Through Innovation
Independently manage quality engineering activities and deliverables supporting manufacturing, validation, and lifecycle management initiatives.
Provide quality engineering support for design and engineering changes by assessing quality and regulatory impact, updating risk and quality documentation, and confirming appropriate verification or validation activities.
Own or support nonconformance reports (NCRs), including containment, investigation, root cause analysis, risk evaluation, disposition, implementation of corrective actions, and effectiveness follow-up.
Lead and support continuous improvement projects by analyzing quality and process data, identifying opportunities, evaluating risk, and implementing sustainable improvements
Review and approve applicable Quality Management System documents and quality records within the role's area of expertise.
Plan and prioritize assigned work independently, participate in project-level planning, and provide technical guidance to cross-functional engineers and stakeholders at all levels, as appropriate.
Support continuous improvement projects by analyzing quality and process data, identifying opportunities, evaluating risk, and implementing sustainable improvements.
Develop and execute verification and validation protocols, including data analysis, statistical rationale, sample size justification, and documentation.
Participate in and lead investigations using structured problem-solving methodologies such as 5 Why, Fishbone, and Fault Tree Analysis.
Identify quality and compliance gaps and contribute to corrective and preventive actions that improve product and process performance.
Analyze quality data and trends to identify improvement opportunities and reduce risk.
Conduct supplier audits and internal audits, and participate in customer and regulatory audits, including audit preparation, documentation review, execution, and follow-up activities.
Partner with suppliers and internal stakeholders to address quality concerns and drive continuous improvement.
Support method validation, equipment qualification, process validation, and manufacturing quality initiatives.
Contribute to a culture of accountability, continuous improvement, and operational excellence.
Your Unique ExpertiseRequired Skills:
Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Life Sciences, or a related technical discipline.
Typically 2-4 years of quality engineering experience within a regulated industry, preferably medical devices.
Working knowledge of Quality Management Systems, ISO 13485, FDA Quality System Regulations, and medical device development processes.
Experience supporting design controls throughout the product development lifecycle.
Understanding of risk management principles and quality engineering methodologies.
Experience participating in investigations, root cause analysis, and corrective and preventive action activities.
Experience developing or supporting verification and validation activities, including protocol execution and documentation.
Strong technical writing skills with experience preparing protocols, reports, engineering assessments, and quality records.
Demonstrated ability to work independently on moderately complex assignments while knowing when to seek guidance.
Strong organizational, planning, and problem-solving skills.
Excellent communication and collaboration skills with the ability to work effectively across functions. Experience supporting audits, inspections, and regulatory compliance activities.
Asset Skills:
Experience within the medical device industry.
ASQ Certified Quality Engineer (CQE) designation.
Professional Engineer (P.Eng.) designation
Experience with Minitab or other statistical analysis software.
Experience supporting process validation, packaging validation, or sterilization validation activities.
Lean Six Sigma certification or continuous improvement experience.
Experience with ISO 14971 risk management practices.
Exposure to global regulatory requirements and international markets.
Our Distinctive Edge
Effortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.
Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.
Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.
Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.
Rewards that count: Reap the benefits of our comprehensive rewards package, including tuition reimbursement and a health spending account.
Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities - fostering camaraderie and fun.
Our ImpactBaylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.
Baylis Medical Technologies is an equal opportunity employer and encourages applications from all qualified individuals.
Please inform us if you require any accommodations during the recruitment process.
We are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make a meaningful impact in the lives of patients. Be part of our mission to revolutionize patient care through cutting-edge technology and breakthrough solutions.
While we thank all applicants, only those being considered for an interview will be contacted.
This role has a base salary range of $73,000 CAD to $90,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.
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