The Senior Quality System Engineer will oversee the responsibilities for the effectiveness and efficiency of the Corrective and Preventive Action (CAPA) process at Nextern. This role will be accountable for the performance of the CAPA system and metrics. This role will provide direction, leadership and training for all Nextern sites ensuring successful implementation, execution and improvement of the CAPA process. This role will also be responsible for supporting and ensuring compliance of global Quality Management System (QMS) processes. This role will be actively maintaining and implementing process improvements to Nextern's Global QMS so that they are properly and timely conducted per Nextern's procedures and business requirements. This role will actively interact with Project Managers, Production personnel, Quality Assurance, Supply Chain, Process Development Engineers and other support functions in Nextern sites, but also externally with suppliers and third parties. DUTIES AND RESPONSIBILITIES: CAPA process owner within Global Quality Systems Ensure CAPA execution, accountability, and due diligence of the team. Monitor and measure the effectiveness of the CAPA process and drive continuous improvement through the CAPA process while interfacing closely with key members of management, CAPA owners, and CAPA team members. Ensure trends are analyzed and CAPA's initiated and executed timely. Develop and implement an ongoing global training program for the CAPA process. Follow all Nextern's policies, practices and procedures to ensure that FDA and ISO regulations along with Nextern quality standards are met. Support QMS processes across all Nextern functions Performs other related duties as assigned by management. Requirements Bachelor's Degree from a four-year college or university, plus 4 years of relevant experience in ISO 13485 and FDA GMP. Relevant experience aligns directly to the job specific responsibilities listed below: Experience with Quality System process improvement including project management. Experience with document management Experience with data analysis and presenting to cross-functional teams and leadership. 2+ years of experience leading root cause analysis investigations. Advanced level of knowledge and execution of root cause analysis tools. Excellent skills in standard computer-based software programs such as Microsoft Office. Excellent learning agility. Ability to effectively build and maintain relationships, communicate, and interact with a variety of personalities. Preferred Qualifications: Agile PLM, Microsoft Power BI, Epicor (ERP) experience or other similar applications, raining/certification in Lean and Six Sigma, Project Management. COMPETENCIES: · Demonstrated skill in effectively analyzing relevant information and reaching independent decisions in a timely manner. · Must be able to formulate and implement mitigations or corrective actions for identified root causes. · Ability to manage difficult projects and bring teams to success · Ability to influence strong team members · Ability to adapt and deal with situations and manage everyone's expectations through ongoing change. Benefits Competitive compensation package.
