About this role
<p style="margin:0.0cm"><strong><span style="">Head of Quality Management – Juarez</span></strong></p> <p style="margin:0.0cm"><strong><span style="">Location:</span></strong><span style=""> Juarez, Mexico<br><strong>Department:</strong> Global Quality Management <br><strong>Reports to:</strong> VP, Global Quality Management <br><strong>Company:</strong> Ambu</span></p> <div style="text-align:center;margin:0.0cm" align="center"><hr align="center" size="2" width="100%"></div> <p style="margin:0.0cm"><strong><span style="">Are you passionate about quality leadership in the medical device industry?</span></strong></p> <p style="margin:0.0cm"><span style="">Ambu is seeking a dynamic and experienced Head of Quality Management for our Juarez site. Join us to drive excellence, ensure compliance, and lead a talented team in a global, innovative environment.</span></p> <div style="text-align:center;margin:0.0cm" align="center"><hr align="center" size="2" width="100%"></div> <p style="margin:0.0cm"><strong><span style="">Key Responsibilities</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Act as Site Quality Management Representative and designated Management Representative.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Oversee and ensure the effective establishment, implementation, and maintenance of the Quality Management System (QMS) in accordance with FDA, ISO, and other applicable standards.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Lead the final release of Ambu A/S and King System products, with authority to stop manufacturing, shipments, and deliveries if quality is at risk.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Initiate recalls, CAPAs (Corrective and Preventive Actions), and NCRs (Nonconformance Reports) as needed.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Approve or reject change requests, validation/verification activities, and product/lot releases.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Coordinate and facilitate Management Review meetings and all external/corporate audits.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Lead the document control process, risk management system, and internal/supplier audit programs.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Ensure all employees are trained in cGMP and familiar with the quality policy.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Manage departmental budget, talent development, and cross-functional teamwork.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Oversee activities related to Micro and Sterilization departments, training, and health/cleanliness policies.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Serve as the primary contact for regulatory authorities and ensure compliance with evolving standards.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Ensuring the proper operation, control, and compliance of cleanroom (controlled environment) areas, including monitoring of environmental conditions, gowning procedures, and personnel behavior to maintain product sterility and compliance with regulatory standards. </span></li> </ul> <div style="text-align:center;margin:0.0cm" align="center"><hr align="center" size="2" width="100%"></div> <p style="margin:0.0cm"><strong><span style="">Qualifications</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Bachelor’s degree in a relevant field.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Minimum 10 years of relevant work experience, including at least 5 years in management and 5 years in the medical device industry.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Proven experience with FDA, ISO, and other regulatory requirements.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Strong leadership, communication, and conflict resolution skills.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Fluent in English (reading, writing, and speaking).</span></li> </ul> <div style="text-align:center;margin:0.0cm" align="center"><hr align="center" size="2" width="100%"></div> <p style="margin:0.0cm"><strong><span style="">What We Offer</span></strong></p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">A key leadership role in a global organization committed to quality and innovation.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">The opportunity to shape quality culture and processes at a critical manufacturing site.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">Competitive compensation and benefits.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm"><span style="">A collaborative, supportive, and growth-oriented environment.</span></li> </ul> <div style="text-align:center;margin:0.0cm" align="center"><hr align="center" size="2" width="100%"></div> <p style="margin:0.0cm"><strong><span style="">Ready to make a difference in healthcare quality?</span></strong><span style=""><br>Apply now to join Ambu as our new Head of Quality Management in Juarez!</span></p> <div style="text-align:center;margin:0.0cm" align="center"><hr align="center" size="2" width="100%"></div>