Why join our team?

Think you have what it takes to work in an organization where creativity, drive and ambition are valued while integrity motivates 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 Opportunity

Deliver leadership and management of UME Quality Operations for all product lines and business initiatives. Lead and manage UME quality teams to facilitate achievement of functional and overall business objectives. Define and implement quality processes to support and enable production operations while ensuring stakeholder requirements are met. Leverage strategic thinking and a risk-based approach to drive quality excellence while maintaining compliance with regulatory standards, including ISO 13485 and FDA QMSR requirements. Implement and maintain electronic Quality Management Systems (eQMS) to enhance efficiency and ensure seamless compliance. Drive continuous improvement initiatives that align with corporate objectives and business strategy while fostering a quality-first culture. Uphold Medicom’s mission and UME’s quality policy while maintaining core values of teamwork, accountability, and customer centricity.

What You Will Do

Leadership and Quality Operations Management

• Leadership and management responsibility for UME Quality Operations function
• Ensure that QMS is effectively implemented, maintained, and continuously improved.
• Strategically develop and implement risk-based quality initiatives to support production, supply chain, and operational excellence.
• Manage the Quality Operations team to support the achievement of business objectives per function organizational strategy and roadmap.
• Ensure QMR objectives align with ISO 13485 and FDA QMSR requirements by integrating key compliance and performance trends. Develop, monitor, and maintain Key Performance Indicators (KPIs) to assess and enhance quality operations, driving timely corrective actions for underperforming areas. Implement a KPI dashboard to track critical metrics, including CAPA effectiveness, non-conformance trends, audit findings, complaint resolution times, QA/QC/RM performance, and overall production quality.
  
  

Regulatory Compliance and Audit Readiness

• Serve as a primary liaison during ISO 13485 surveillance audits, FDA inspections, and customer audits.
• Support QSC corporate and internal audit program, ensuring gaps are proactively addressed through CAPAs and continuous improvement efforts.
• Ensure quality operations processes comply with applicable regulatory standard requirements, including but not limited to document control, labeling, traceability, and supplier management Product Quality & Risk-Based Decision Making
• Own CAPA, non-conformance, risk management, and complaints to ensure product quality while implementing proactive risk management strategies (FMEA, risk-based thinking) to prevent compliance and production issues.
• Ensure quality operations align with regulatory standards, including supplier risk assessments and monitoring.
• Support Corporate Supplier Quality in qualification, monitoring, and risk assessment for ISO 13485 compliance, leading supplier CAPA and SCAR investigations to resolve quality issues.
  
  

Process Validation & Change Control

• Support and facilitate compliance, efficient, and risk-based execution of process validation (IQ/OQ/PQ), equipment qualification, and change control management, ensuring production process validations meet quality standards and industry best practices
• Ensure all validation activities align with ISO 13485 requirements and are properly documented within the eQMS. QMS
  
  

Digitalization & eQMS Implementation

• Lead the implementation and optimization of an eQMS to streamline quality processes, enhance data integrity, and improve audit readiness.
  
  

Team Leadership & Development

• Develop and grow high-performing Quality Teams to support operational quality activities and objectives.
• Foster a culture of quality excellence and continuous improvement by implementing structured training programs on ISO 13485, risk management, and QMS compliance.
• Motivate, organize, and encourage teamwork within the team and cross-functional departments.
• Ensure all employees are trained and aware of ISO 13485 requirements and the importance of a robust QMS.
  
  

What you will bring

• Bachelor’s Degree in life sciences or related technical discipline.
• 10+ years of experience within the quality/regulatory/compliance discipline, preferably in a regulated medical device industry
• 5+ years of management experience with a strong understanding of ISO 13485 implementation.
• Demonstrated history of successful quality and compliance leadership, with expertise in ISO 13485 implementation and maintenance.
• Strong experience with eQMS implementation, digital quality metrics, and automation of compliance tracking.
• Ability to explain and resolve differences in interpretation of standards, regulations, and operational quality requirements.
• Strong written and verbal communication skills, especially with regulatory agencies and/or certification bodies.
• Advanced degree and/or professional certification in quality/regulatory/compliance.
• Proven ability to apply a risk-based approach to quality management, ensuring compliance while optimizing operational efficiency and mitigating potential risks.
  
  

Equal Opportunity Employer

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.

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!