The Big Picture

The Senior Manager, Quality Engineer is responsible for coaching and directing the quality team in establishing, maintaining and improving the company's quality system according to regulatory and company requirements. Supports and executes delegated Quality System Management Representative responsibilities, as assigned by the Director.

Your Impact Through Innovation

• Establishes and maintains adequate quality systems, policy, objectives, and metrics and ensures resources are adequate, appropriate and competent to support the quality system to ensure quality and reliability of products and services supplied by Baylis Medical Technologies

• Acts as a delegate of the Quality System Management Representative, as assigned by the Director

• Ensures compliance of the quality system to ISO 13485 and government regulations in marketed jurisdictions

• Partners with the Director to develop and deploy quality strategies aligned with business objectives, driving continuous improvement in product and service quality

• Champions the quality culture and builds outstanding partnerships with operations, supply chain, manufacturing, regulatory, research and development, sales, and other functions

• Develops quality capabilities, training and coaching for the quality team and rest of company as applicable; Build future leaders for the organization

• Makes critical, creative and strategic decisions as a result of analysis of available information including risk-assessment for the patient and for the business

• Provides senior oversight for design and manufacturing quality activities, ensuring appropriate application of design controls, risk management, and production controls across the product lifecycle.

• Partners with R&D, Manufacturing, and Operations to ensure effective transfer of new products and technologies, including readiness of quality processes, controls, and risk documentation.

• Ensures product and process risk management activities are appropriately defined, implemented, and maintained in alignment with ISO 14971.

• Provides governance and direction for nonconforming material and MRB processes, ensuring consistent decision making, escalation, and systemic corrective action.

• Oversees the supplier quality framework, including expectations for supplier qualification, performance monitoring, change management, and issue escalation, while delegating execution to functional quality teams.

• Ensures manufacturing quality controls and inspection strategies are fit for purpose, risk based, and aligned with regulatory and business requirements.

• Provides senior oversight of sterility assurance and environmental control programs, ensuring appropriate governance, risk management, escalation, and continuous improvement. Ensures responsibilities, controls, and monitoring are clearly defined and effectively executed by functional teams.

• Possible need to travel.

• Other duties as required.

Your Unique Expertise

######Required Skills:

• Minimum Bachelor’s degree in a scientific or engineering discipline
• Minimum of 8 years’ experience in medical device industry or equivalent industry
• Minimum of 5 years’ experience in manufacturing environment
• Minimum of 5 years’ experience leading and coaching others in a Quality role
• Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others
• Demonstrated working knowledge of and experience with U.S. FDA medical device regulatory requirements, including the Quality Management System Regulation (QMSR) and ISO 13485, as well as Canadian Medical Devices Regulations (CMDR)
• Strong understanding of ISO 14971 risk management principles
• Demonstrated experience in hosting and facilitating audits and regulatory agency inspections with successful outcomes.
• Demonstrated skills in achieving results and managing others to achieve objectives
• Demonstrated experience in making decisions to resolve the most complex problems and providing sound compliance advice and direction
• Demonstrated successful interdisciplinary collaboration in a team setting
• Strong expertise in analytical methods, quality systems and continuous improvement methods
• Skilled interpersonally; strong communication, negotiation and conflict management skills
• Demonstrated proficiency in project management, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation

######Asset Skills:

• Advanced degree in engineering, life sciences or related field

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 accommodation 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.

Are you ready to join us? Apply today and let’s shape the future of healthcare together!

Want an inside look at careers and life at Baylis? See all our current job opportunities hereand 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 $143,000 CAD to $197,000 CAD. Final offers are determined based on individual skills, experience, qualifications, location, and other job-related factors.