Do you think you have what it takes to work in an organization where creativity, ambition and initiative are valued, and where integrity drives everything we do?
Medicom has been in business for over 35 years, and it has kept its entrepreneurial mindset. Working with us, you will have the opportunity to get involved, have an impact, and contribute to the company’s continued growth. We live by our values every day, focussing on customer satisfaction while ensuring teamwork, accountability, and empathy in everything we do.
Our team loves challenges and a fast-paced environment. You will have the flexibility to manage work and a personal life, as well as your own personal well-being. We offer an attractive compensation package with benefits.
The Quality Engineer will collaborate, lead, and support cross-functional teams on the quality and regulatory requirements to ensure company and industry compliance with requirements throughout the product lifecycle. The Quality Engineer is responsible for supporting and leading activities within the quality management system as well as participating in cross-functional team projects.
This posting is for a newly created position to support our continued growth.
Quality System Management
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Assist with the development and implementation of a robust and compliant quality management system (QMS) aligned with industry standards including ISO 13485:2016 and the Canadian Medical Devices Regulations (CMDR).
- Support the maintenance and updating of quality procedures, and documentation as required.
- Assist with conducting internal audits to identify areas for improvement and ensure compliance.
Product Development Support
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Actively participating in cross-functional product development teams, ensuring quality is integrated into design and manufacturing processes from concept to design transfer and launch.
- Reviewing design documents, specifications, and risk assessments to identify potential quality issues.
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Supporting the development and execution of process validation and verification protocols and procedures.
Supplier Quality Management
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Support Purchasing with the evaluation and approval of suppliers for raw materials and services to ensure they meet quality and company requirements.
- Managing supplier quality issues and implementing corrective actions.
Non-Conformance and Corrective and Preventive Action
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Investigating non-conforming materials and products, identifying root causes, and implementing corrective and preventive actions, as appropriate, following the CAPA procedure to prevent recurrence.
- Managing the non-conformance reporting system and ensuring timely resolution of issues.
- Manage customer complaints including trending and follow-up actions as required.
Quality Assurance Activities:
- Analyzing quality data to identify trends and implement continuous improvement initiatives.
- Assist with employee training activities to support site training plan.
May include other related duties as required, provided such duties are reasonable and consistent with the employee’s qualifications and role responsibilities.
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Minimum 3 years’ experience in medical device quality management systems, or relevant fields
- Bachelor’s degree in Engineering or related field
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Solid knowledge of ISO 13485, FDA regulations, and other applicable quality and regulatory standards within medical device or PPE manufacturing environments
- Proficiency in quality analysis and problem-solving methodologies (e.g., root cause analysis, CAPA, continuous improvement tools) to drive product and process improvements
- Strong communication and interpersonal skills, with the ability to effectively collaborate across cross-functional teams (Operations, Engineering, Quality, Supply Chain)
- Demonstrated experience leading quality initiatives, with a focus on continuous improvement and operational excellence
- Excellent organizational and prioritization skills, with the ability to manage multiple stakeholders and project timelines effectively
- Ability to thrive in a fast-paced, project-based environment, demonstrating adaptability and resilience under pressure
- High level of attention to detail, rigor, and accuracy in all aspects of quality management
- Self-driven with a strong sense of ownership, autonomy, and proactive problem-solving, including the ability to propose and implement improvements
Compensation
The expected base salary range for this position is $70,560 – $85,000 per year.
Actual compensation will be determined based on experience, skills, education, internal equity, and other job-related factors permitted by law.
Depending on the role, the position may be eligible to participate in a bonus or incentive program.
Benefits & Work Environment
- Comprehensive insurance program including EAP and telemedicine for you and your family.
- Company-matched retirement plan.
- Opportunities for training, coaching, and professional development.
- A dynamic and friendly work environment, with an active social committee organizing events such as sports activities, BBQs, and family gatherings.
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Work is performed in a combination of office and manufacturing environments
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The role requires regular on-site presence in production areas and extended periods of computer and screen use
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Standard work schedule is daytime hours; however, occasional attendance outside regular hours (including early, late, or shift-based hours) may be required to support commissioning, operational needs, or improvement activities
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Occasional travel may be required based on business needs
Medicom is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.
Medicom is committed to providing an accessible recruitment process. We will make reasonable efforts to provide accommodations to applicants with disabilities during the recruitment process. If you require an accommodation, please let us know when you are invited to participate in the selection process.
Medicom may use artificial intelligence (AI) and digital tools to support certain aspects of the recruitment process, such as candidate sourcing, screening, and interview scheduling. These tools are used to assist our recruiters and do not make final hiring decisions.
If you are energetic, committed to making a difference and love challenges, we would love to hear from you. Visit our website at Careers - Medicom and apply today!
