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.
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.
