Non-Conformance (NC) CAPA Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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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 were 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 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

Key Responsibilities:

• Willassist inthorough investigation and documentation of quality issues and monitor implementation of effective corrective and/or preventive 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 analysisdevelopment 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

Qualifications

Education:

• Bachelor of Science degree or equivalent in Life Science Physical Science or Engineering is required

Experience and Skills:

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

Preferred:

• EtQ QuIn and Minitab experience.

Other:

• This position may require up to 5% travel both domestic and international.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

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