Quality Engineer III

Baylis Medical Technologies Inc.; Mississauga; Hybrid; CAD 73,000 - 90,000; Full time

Benefits offered by this job

Hybrid work model

Shuttle/Transit assistance

Volunteer day off

On-site training and development

Tuition reimbursement

Health spending account

Job summary

Baylis Medical Technologies Inc. is seeking a Quality Engineer III in Mississauga, Canada, to manage quality engineering activities across manufacturing and product lifecycle.

You will lead investigations, drive continuous improvement, and ensure compliance with regulatory and quality requirements. The role emphasizes design changes, risk management, verification/validation, and collaboration with R&D, Regulatory Affairs, Operations, and Supply Chain.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 2-4 years of quality engineering experience in a regulated industry (medical devices preferred).
• Experience with Quality Management Systems (ISO 13485, FDA QSR) and product development processes.
• Experience with design controls throughout product lifecycle.
• Strong risk management and problem-solving skills.
• Experience with investigations, root cause analysis, and CAPA activities.
• Experience developing/ supporting verification and validation activities with protocols and documentation.
• Strong technical writing and cross-functional collaboration skills.
• Experience with audits, inspections, and regulatory compliance.

Responsibilities

• Independently manage quality engineering activities supporting manufacturing and lifecycle initiatives.
• Assess quality and regulatory impact of design/engineering changes; update risk and quality docs.
• Own or support NCRs from containment to corrective actions and follow-up.
• Lead continuous improvement projects by analyzing data and implementing sustainable improvements.
• Review and approve QMS documents and quality records within area of expertise.
• Plan and prioritize work; provide technical guidance to cross-functional engineers.
• Develop and execute verification and validation protocols with data analysis and justification.
• Lead investigations using structured problem-solving methods (5 Why, Fishbone, FTA).
• Identify gaps and contribute to CAPA that improve product/process performance.
• Analyze quality data to identify improvement opportunities and reduce risk.
• Participate in supplier and internal audits, and customer/regulatory audits.

Skills

Quality engineering

Regulatory compliance

Design controls

Risk management

Investigation & RCA

Verification & validation

Documentation

Audits & regulatory

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

Job description

• Pay or shift range: $73,000 CAD to $90,000 CAD. The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Description

The Big Picture

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.

Required 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 Impact

Baylis 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.

Take the Leap

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.

Want an inside look at careers and life at Baylis? See all our current job opportunities here and follow us on LinkedIn !

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.