Quality Manager

Order Type : Direct Hire

Pay: 125K - $140K + 10% bonus (10% bonus is based on employee goals/performance and its 10% of the employees annual salary if goals are met) ***NOT A REMOTE POSITION JOB SUMMARY 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. SKILLS, KNOWLEDGE AND ABILITIES REQUIRED: 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. REQUIRED: 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. KEY RESPONSIBILITIES 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.