QA CAPA Manager

KARL STORZ United States is currently recruiting a CAPA Manager who will be responsible for supporting the development, deployment, maintenance, and improvement of the Corrective Action and Preventive Action (CAPA) Management processes and procedures within the KARL STORZ (KS) organization.  This role will ensure effective deployment of CAPA requirements (both internal and external) into the division and corporate procedures, provide leadership and/or represent Quality Affairs corporate improvement teams focused on CAPA Management and ensure conformance to global quality management regulations, KS quality policies and standards, and key performance indicators.

This is an onsite role and can be based in Goleta, CA, Stafford, TX or Charlton, MA. 

Responsibilities

• Facilitate root cause investigations and developing corrective and preventive measures.
• Carry out the effectiveness controls.
• Monitor and track measures and CAPA phases.
• Ensure complete and adequate documentation of the CAPA.
• Manage and moderate CAPA team meetings.
• Provide guidance and direction of the CAPA systems Body-of-Knowledge.
• Provide subject matter expertise, leadership, and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.
• Support audits and regulatory inspections US location as a global CAPA subject matter expert.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Produce and analyze trend metrics & reports and establish further actions, as required.
• Represent the CAPA organization on interdivisional committees to drive continues improvement across the corporation.
• This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Manage the execution of goals.
• Accountable to the Quality Organization for achieving mutually agreed upon objectives.
• Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality, and Regulatory.
• Decisions and recommendations made by this position directly influence and impact the quality of marketed products and the effectiveness of KARL STORZ’s Quality System to applicable regulations.

Requirements

• Bachelor’s Degree or other qualifying experience

• 5+ years working in a quality management system environment, with direct experience working with CAPAs in a regulated environment.

• Experience in auditing quality management systems ( ISO 9001 or ISO 13485)
• EU Directives, particularly European Medical Device Regulations
• EN ISO 9001, ISO 13485, Quality System standards
• FDA Quality System Regulation 21 CFR Part 820 and other related FDA regulations
• ISO 14971 Risk Management standard
• European Union Medical Device Regulation

• Knowledge of standards and laws applicable to medical devices, such as ISO 13485, 21 CFR Part 820
• Knowledge of Statistics
• Proficiency in MS Office; working knowledge of Tableau a plus

• Leading cross-functional teams to accomplish goals and objectives.

• Demonstrated experience in root cause analysis, critical thinking, and problem solving methodologies
• Excellent written and spoken communication

• Ability to reliably work independently
• Hands-on mentality
• Develop and maintain productive and effective relationships with regulatory authorities and coworkers.
• Ability to work constructively and cooperatively with employees at all levels in the organization.
• Effective leadership in a multi-disciplined team setting through communication, education, and mentoring.
• Ability to travel approx. 10-25%

• Ability to lift, on occasion, approximately 20lbs.

Preferences

• Master’s Degree in Technical Field or Quality
• Six Sigma Certification
• Certificate of completion in lead auditor training for ISO 9001 or ISO 13485
• 7+ years’ experience in quality management in the medical technology or pharmaceutical industry. Ideally in the areas of Measurement, Analysis, Continuous Improvement, CAPA, Quality Systems.
• 2+ years team leading, supervising, or project management.

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