CAPA Manager - Molecular Solutions

United States of America, Arizona, Tucson

de fr es ru tr it pt zh ja

Assess and provide a clear vision of CAPA compliance and effectiveness across the Molecular Solutions organization through creating and driving strategy, direction, management and oversight of the corporate CAPA program.  Ensure successful integration, maintenance, and continuous improvement of the Molecular Solutions CAPA process in a customer-centric manner with focus on systemic root cause. This position interacts directly with both external and internal stakeholders, including but not limited to Regulatory Agencies/Health Authorities, Functional SMEs  as the Subject Matter expert and ensures that the company’s CAPA process maintains compliance with internal and external standards and regulations (i.e. 21CFR 820.198, ISO 13485:2016,  ISO 14971, IMDRF).

Responsibilities:

  • Provide high level management of the MS CAPA process to contribute to the continuous improvement strategy of the Quality Management System (QMS) including,  but not limited to, process improvements and harmonization.
  • Lead assigned Corrective Action/Preventive Action (CAPA) projects across Molecular Solutions, when appropriate. This includes, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan, and submitting a summary report for project closure and conduct effectively checks (EC).
  • Provides oversight to the activities of the CAPA Review Board(s) (CRB) for Molecular Solutions to ensure a complaint and consistent approach to CRB activities.
  • Ensures compliance t o site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate
  • In-Depth understanding and application of risk management practices for use in assess and approaches in design and manufacturing environments; 
  • Responsible for overseeing the analysis of CAPA data sources across Molecular Solutions to identify differences in trends and take action where appropriate.  key decisions and strategy related to internal operations, customer support decisions, and product projects.
  • Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
  • May perform other duties as required or assigned.
  • Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
Knowledge, Skills and Abilities:
  • Bachelor's Degree in a Life Sciences or technical discipline, or equivalent (Master's degree preferred)
  • Nationally recognized certification in a quality or regulatory function (i.e. ASQ Certified Quality Auditor, Certified Quality Engineer,  certification) preferred
  • 7 - 10 years medical device experience required
  • 3 - 5 yea rs as a supervisor or manager of teams required
  • Experience in FDA regulated industry required
  • Experience with implementation of compliance to international regulations
  • Excellent understanding of quality principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
  • Thorough understanding of a Quality System and its development, documentation and implementation with respect to domestic and international standards and requirements.
  • Strong time management, organizational, interpersonal, written and communication skills with the proven ability to manage and prioritize multiple projects and meet deadlines.
  • Ability to lead, organize, collaborate and motivate teams. Ability to work and collaborate globally and work with all levels of employees.
  • Good understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers  to quality improvements
  • Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across functions.
  • Ability to execute tasks with high degree of accuracy and quality.