Manager, Quality and Regulatory

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.

Deliver leadership and management of the MML Quality and Regulatory function for all start-up operations and business initiatives. Lead and manage MML quality teams to facilitate achievement of functional and overall business objectives. Define and implement quality/regulatory processes to support and enable production start-up operations while ensuring stakeholder requirements are met. Utilize risk-based critical thinking leadership approaches to assure compliance with quality/regulatory requirements while simultaneously meeting business objectives.

Drive implementation of functional strategy and roadmap, and identify and define quality and regulatory compliance requirements for MML operations to stakeholders throughout the company. Drive continuous improvement initiatives that align with corporate objectives and business strategy while fostering a quality-first culture in start-up project. Uphold Medicom’s mission and MML’s quality policy while maintaining core values of teamwork, accountability, empathy and customer centricity.

• Leadership and management of the MML Quality and Regulatory function and team to support the achievement of business objectives per function organizational strategy and internal Medicom standards.
• Implement risk-based quality initiatives to support quality/regulatory compliance, production, supply chain, and operational excellence.
• Lead, coach, mentor and develop high-performing MML quality team with emphasis on standardization and consistency of function organizational operating model.
• Facilitate compliant, efficient and risk-based execution of top-level and sub-level processes as applicable in areas of Quality Governance, Quality Systems and Compliance, Design Quality, Regulatory, Supplier Quality and Quality Operations.
• Assure quality throughout product realization process including ownership of inspection, QA/QC, product release, quality engineering, non-conformance, production process validation, equipment qualification, analytical method validation, and CAPA processes
• Ensure quality objectives align with ISO 13485 and FDA QMSR requirements by integrating key compliance and performance trends. Develop, monitor, and maintain KPIs to assess and enhance quality operations, driving timely corrective actions for underperforming areas.
• Serve on MML Leadership Team with responsibility to lead the collective business, set and maintain strategic direction, and direct teams to ensure achievement of strategic and operational business objectives.
• Drive QMS process development, QMS continuous improvement and standardization to serve business objectives.
• Ensure all process and computer software assurance validation activities for MML align with ISO 13485 requirements and internal standards.
• Lead and drive to completion new ISO 13485 MDSAP QMS certification of MML site. Serve as a primary liaison during ISO 13485 surveillance audits, FDA inspections, and customer audits.
• Lead implementation and maintenance of Medicom standard eQMS system for MML site.
• Support QSC internal audit program, ensuring gaps are proactively addressed through CAPAs and continuous improvement efforts.

• Bachelor’s degree in engineering, life sciences, quality/regulatory or related technical discipline
• 10+ years of experience within the quality/regulatory/compliance discipline, preferably in a regulated medical device industry
• 5+ years of…