Non-Conformance (NC) CAPA Lead

Johnson & Johnson•San Angelo, TX

4d•Onsite

About The Position

Ethicon San Angelo is recruiting for a Non-Conformance (NC) CAPA Lead, located in San Angelo, TX. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The NC Lead is responsible for ensuring the management and reporting of data from the NCR and CAPA process at the San Angelo, TX facility. Performs quality support duties including maintenance of the corrective action and preventive action (CAPA) and supplier systems. Provides support for special quality projects. Ensures and maintains a state of inspection readiness. Perform in various quality functional areas and maintain expertise. Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Provide support during Notified Body, Competent Authority, Franchise, Customer and Internal Audits Identify, support and lead NCR and CAPA Quality subsystem improvements, which result from audits and any other Quality subsystem indicators Perform other work-related duties as assigned by Quality Systems and Compliance Lead Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001). Responsible for communicating business-related issues or opportunities to next management level Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed

Requirements

Bachelor of Science degree or equivalent in Life Science, Physical Science or Engineering is required
2 to 4 years of relevant experience in the medical device, pharmaceutical or other highly regulated industry is required, with quality function experience preferred
Knowledge of Quality Systems Standards (BS EN ISO13485; FDA Medical Devices Quality Systems Regulation 21 CFR 820; Medical Device Directive 93/42/EEC)
Knowledge in database administration and data manipulation for analysis and reporting purposes
Knowledge and proficiency in standard computer applications
Data interpretation and analysis / graphing
Ability to draw conclusions through data analysis to influence actions that improve quality and reduce risk
Strong verbal and written communication skills and a collaborative, team-oriented work ethic
Ability to manage multiple items concurrently
Strong organization skills to address hundreds of NC / CAPA items that may be active at any time

Nice To Haves

EtQ, QuIn and Minitab experience.

Responsibilities

Will assist in thorough investigation and documentation of quality issues and monitor implementation of effective corrective and/or preventive action.
Follow up on closure of corrective and preventive actions
Will track/trend quality issues and/or process data over time for assigned quality processes and generate reports to management
Gathers data and documents for audits and inspections.
Ensures and maintains a state of inspection readiness
Will ensure effective and efficient use of tools such as risk analysis, test method development, statistical data analysis, development of sampling plans, etc.
This individual will lead the review of process risk assessment
Support the development and implementation of effective policies, requirements and strategies for Quality Management System sub systems including, but not limited to NCR, and CAPA
Monitor and ensure Due Date Adherence for NCR and CAPA Quality Subsystems
Ensure that Quality subsystems are optimized to provide the most effective methods of compliance with internal, European, Franchise and Regulatory standard requirements
Liaise with relevant Worldwide Quality Systems and Compliance groups to ensure local representation is maintained across NCR and CAPA Quality system activities
Provide regulatory interpretation, training and assessment within the organization to ensure NCR and CAPA Quality subsystems are aligned with current requirements, standards and industry trends
Administer relevant Quality subsystem applications and processes in compliance with corresponding Franchise requirements