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Director Global CAPA Programs (Remote, US)
<span class="jobdescription"><p><img alt="" src="https://www.getinge.com/siteassets/start/company/careers/Global_careers-portal90122.jpg"></p> <p style="line-height:normal"> </p> <p style="line-height:normal"> </p> <p style="line-height:normal"><span style="font-size:18.0px"><span style="font-family:Arial, Helvetica, sans-serif"><b><span style="color:#18274a">With a passion for life</span></b></span></span></p> <p style="line-height:normal"> </p> <p style="line-height:normal"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. </span></span></span></p> <p style="line-height:normal"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">Are you looking for an inspiring career? You just found it.</span></span></span></p> <p style="line-height:normal"> </p> <p> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Job Overview</span></strong></p> <p><span style="font-size:12.0pt">Responsible for leading Getinge Global CAPA Continuous Improvement activities supporting Getinge by addressing three core challenges: Competency, Culture and Complexity with the goal to build expertise, foster shared accountability and simplify processes to enable faster, more effective problem resolution and continuous improvement across the Getinge organization. The position supports Getinge’s products under the Acute Care Therapy, Surgical Workflow and the Life Science business areas.</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Job Responsibilities and Essential Duties</span></strong></p> <ul style="margin-top:2.0pt;margin-bottom:1.0 E-4pt"> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Lead cross functional teams to upgrade and improve performance of Getinge’s end-to-end CAPA System (NC and CAPA).</span></li> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Assesses health of system (compliance, efficiency, performance) and manages a portfolio of improvement projects.</span></li> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Support Getinge Entities in audit (internal and external) activities.</span></li> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Engage with stakeholders, including customers and suppliers, to gather feedback and ensure that their requirements are integrated into the Getinge CAPA system.</span></li> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Ensure compliance with the company’s Quality System policies and procedures.</span></li> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Conduct training sessions and workshops and serve as a CAPA coach to educate resources on the CAPA System. </span></li> <li style="margin:2.0pt 0.0in 1.0 E-4pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Participate in industry & FDA conferences to stay current on enforcement priorities and upcoming changes.</span></li> <li style="margin:6.0pt 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">The position will be responsible for developing and managing personnel</span></li> <li style="margin:0.0in 0.0in 3.0pt 0.0px;line-height:115%;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;line-height:115%;font-family:Aptos, sans-serif;color:black">Internal and External Contacts/Relationships include</span><strong><span style="font-size:11.0pt;line-height:115%;font-family:Aptos, sans-serif;color:black"> </span></strong><span style="font-size:11.0pt;line-height:115%;font-family:Aptos, sans-serif;color:black">Quality & Regulatory Affairs Senior Leaders, Global Process Caretakers, Functional leads in BA (ACT, SW, LS), Global Sales & Service and Operational Services (Logistics), Local Quality Managers (LQMs) and Global Regulators – FDA, Notified Bodies, Competent Authorities, etc.</span></li> </ul> <p style="background-color:white;margin:6.0pt 0.0in 0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Required Knowledge, Skills and Abilities</span></strong></p> <ul style="margin-top:3.0pt;margin-bottom:3.0pt"> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">Master’s Degree in a relevant field (e.g., Business Administration, Quality Management, or other related science discipline or equivalent combination of education and experience is required). </span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;background-color:white;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif;color:black">A minimum of 10 years related experience in a medical device quality process areas</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Subject matter knowledge in CAPA and NC processes (CAPA System)</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Strong understanding of Quality Management System operations and application of Global Regulations, ISO standards and management controls.</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">High level of influence and mediation skills; can facilitate bringing people from different perspectives to consensus.</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Internal and External Audit Experience; participation in observation response writing and/or working groups.</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Consent decree and remediation activities</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Strategic QMS thinker with excellent analytical and problem solving skills</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Demonstrated ability to work collaboratively in a cross-functional, matrixed environment.</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">General understanding of reporting tools (Crystal Reports, Power BI)</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Effective written and verbal communication, including technical writing skills</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Proficiency with Microsoft Office Suite (Word, Excel, Outlook, Teams, Sharepoint, Powerpoint)</span></li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"><strong><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Preferred Qualifications:</span></strong></p> <ul style="margin-top:3.0pt;margin-bottom:3.0pt"> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Trackwise application experience</span></li> <li style="margin:3.0pt 0.0in 3.0pt 0.0px;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:11.0pt;font-family:Aptos, sans-serif">Certification in quality management (e.g., Six Sigma, CQM, ISO Lead Auditor) </span></li> </ul> <p style="margin:3.0pt 0.0in 3.0pt 0.25in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0in 0.0in 1.0 E-4pt 0.25in;font-size:12.0pt;font-family:Arial, sans-serif">The base salary for the position is a minimum of $183,000 and a maximum of $210,000, plus annual bonus of 30%</p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Arial, sans-serif"> </p><p> </p> <p><span style="font-size:14.0px"><b><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">About us </span></span></b></span></p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.</span></span></span></p> <p> </p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><span style="color:#595857">Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.</span></span></span></p> </span>