Ethicon, Inc., a member of the Johnson & Johnson's Family of Companies, is recruiting for a Quality Systems Specialist, NCR and CAPA located in San Angelo, TX.
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.
Responsible for ensuring the management and reporting of data from the NCR and CAPA process at the San Angelo, TX facility.
ESSENTIAL FUNCTIONS/DUTIES and RESPONSIBILITIES
• Support the development and implementation of effective policies, requirements and strategies for Quality Management System sub systems including, but not limited to NCR (Non-Conformance Reporting), and CAPA (Corrective and Preventive Actions)
• 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 World Wide Quality Systems and Compliance groups to ensure local representation is maintained across NCR and CAPA Quality system activities
• Involvement in / awareness of developments within the NCR and CAPA Quality Subsystems with a view to ensuring alignment of local processes and procedures
• 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
• Provide Quality subsystem process performance measurements to Quality and Operations Management as required
• Work effectively with other Quality and Operations associates to ensure consistent and compliant Quality subsystems
• Effective alignment and execution of objectives supporting appropriate WWQS & QC outcomes
• Provide support during Notified Body, Competent Authority, Franchise, Customer and Internal Audits
• 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 environmental, safety and occupational health policies. (i.e., ISO14001 & OSHAS18001) Qualifications
• A minimum of a Bachelor’s Degree is required, Life Science, Physical Science, Engineering or equivalent is preferred.
• A minimum of 2-4 years of experience in related systems is required.
• Experience with Non-Conformances or Corrective and Preventive Action’s is required.
• Knowledge of Quality Systems Standards (BS EN ISO13485: 2003; FDA Medical Devices Quality Systems Regulation 21 CFR 820; Medical Device Directive 93/42/EEC) is preferred.
• Knowledge in database administration and data manipulation for analysis and reporting purposes is strongly preferred.
KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES and LANGUAGES
• Data interpretation and analysis / graphing is preferred.
• Ability to draw conclusions through data analysis to influence actions that improve quality and reduce risk is preferred.
• Good verbal and written communication skills with a good team working ethos
• Ability to manage multiple items concurrently is required.
• Strong organization skills to address hundreds of NC / CAPA items that may be active at any time is required.
• This position may require up to 10% travel and will be based in Ethicon San Angelo, TX manufacturing facility.
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LI NAPrimary Location
United States-Texas-San AngeloOrganization
Ethicon Inc. (6045)Job Function