HireDiversity

Cincinnati, OH, US

Global CAPA and Escalation Manager-8270121211

Description

The Ethicon Surgical Care business of the Medical Device and Diagnostics sector of Johnson & Johnson is recruiting for a Global Corrective and Preventive Action (CAPA) and Escalation Manager, to be located in Cincinnati, OH.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Global CAPA and Escalation Manager provides Global Corrective and Preventive Action (CAPA) and Escalation process leadership by driving improvements in product and process performance, reviewing quality issues to assure appropriate actions are taken, and overseeing related field action activities. This individual is responsible for the effectiveness and efficiency of the Global Corrective and Preventive Action Process. Responsible for the effectiveness and efficiency of the process of escalating significant quality issues, up to and including QRB, and the execution of related Field Actions. Reports to the Director, Quality System and Regulatory Compliance.

The Global CAPA and Escalation Manager is the CAPA process owner, and drives execution through Site CAPA Coordinators. This individual is accountable for performance of global CAPA system and metrics. Provides direction and leadership for CAPA Site Leaders resulting in each site successfully implementing, maintaining and improving the CAPA process. This is a leadership role with the Franchise CAPA Councils responsible for achieving EES quality goals. Develops and implements an ongoing education process for the CAPA process. Develops and implements measures to monitor the effectiveness of the CAPA and Escalation process and drive remediation for improvement. Organizes and coordinates the Corrective and Preventive Action Process and Escalation Process investigation and implementation teams for root cause analysis, issue bounding and corrective and preventive action. Ensures CAPA and Escalation process execution, accountability, and due diligence. Ensure that trends are analyzed, CAPA's are initiated and completed as required, and related Escalations and Field Actions are executed.

This individual represents CAPA and Escalation process and outputs in internal and external audits. Supplies the status of CAPA and Escalation performance and Field Action Status to Executive Management Review process. Drives continuous improvement through the CAPA process while interfacing closely with key members of management, the Corrective and Preventive Action Process Owners, and Site CAPA coordinators to facilitate the effectiveness of the Corrective and Preventive Action Process. Owns Risk Management Board Meeting efficiency, effectiveness and output. This individual is an ETQ Business Process Owner and drives improvements in system reporting and accessibility. Executes the Escalation process (HHE, QRB, Field Action) to assure significant quality issues are reviewed and appropriate actions are taken. Manages Field Actions that result from the Escalation process. This includes interfacing with FDA Field Office, coordinating recall activities with third party recall processors, developing field action communication material, and documenting field action activities. Supervises direct reports. Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Qualifications


A BA/BS degree or equivalent is required. A degree in a Life Science, Engineering, Business or Physical Science is preferred. An advanced degree is preferred. ASQ Certified Quality Manager, Certified Quality Auditor, and/or Certified Quality Engineer certification is preferred. Black Belt or Green Belt certification from a recognized PE program is preferred.

A minimum of 5 years of proven success in quality management and compliance is required. A minimum of 5 years experience in the medical device or pharmaceutical industry is highly preferred. Understanding of Quality Systems and/or Quality Assurance is required. Broad experience utilizing Quality Systems is preferred. Spanish fluency is a plus. Experience communicating CAPA and escalation of quality issues to management is required. Strong capability of influencing and engaging at multiple levels within the organization is required. Demonstrated skill in effectively analyzing relevant information and reaching independent decisions in a timely manner is required. Demonstrated proficiency in the interpretation and application of Medical Device QSR, Pharmaceutical GMP, Medical Device Directive, ISO 13485, ISO 14971, and other applicable international standards is highly preferred.

Strong presentation skills including presentation of data, and the ability to cohesively describe quality issues is required. Demonstrated leadership in managing FDA / Notified Body compliance inspections is required. Demonstrated ability to apply statistical tools is preferred. Practical experience in Lean principles is preferred. Personal computer skills including windows, word processing, project planning, presentation, email and spreadsheet software, database management, and desktop publishing is required. Experience with statistical software (ideally Minitab and Stat Graphics) is preferred.

Up to approximately 10% domestic and international travel may be required. This position will be located in Cincinnati, OH.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)