J&J Family of Companies Compliance Engineer in San Angelo, Texas
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Compliance Engineer, this role will be 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. 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. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
You, the Compliance Engineer will ensure the continuous education, implementation and improvement of site Compliance with FDA regulations, ISO standards and any additional regulations and standards applicable to the site such as 21 CFR Parts 4, 211 and 820, ISO13485, MDD/MDR, CMDR, TGA, JPAL and ANVISA requirements.
ESSENTIAL FUNCTIONS/DUTIES and RESPONSIBILITIES
External inspection readiness and associated activities. Support site audit readiness activities to ensure inspection readiness at all time.
Support external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site.
Participate in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.).
Support mock inspections as part of External Inspection Readiness activities.
Provide timely information to support the inspection process.
Internal Audit Program and Management Execution
Execute against established internal audit procedures.
Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.
Drive compliance and improvement in internal audit metrics.
Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
Enterprise / Sector Support
Connect and collaborate with other regions compliance teams.
Metrics Collection and Reporting
Create reports and communicate performance against metrics to key stakeholders.
Highlight/communicate adverse trends in metrics, and take risk based action to remediate.
Escalate items in accordance with established procedures.
External Standards and Regulations
Support implementation of new external standards/regulations for the site.
Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
Site Management Review
Provide input into Site Management Reviews (e.g., internal audits.) to allow meaningful review.
Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001)
Establish strong connection and collaboration with business partners at the site, (e.g. Quality Operations, Training, and Manufacturing).
Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
A Bachelor’s degree is required, a concentration in Engineering and/or scientific discipline is preferred.
A minimum of 2-4 years related experience, e.g. within a manufacturing environment. Experience in a highly regulated industry (Pharmaceutical, Medical Device, Diagnostics, Biotechnology, Automotive, Defense Aerospace, etc.) is also required.
KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES and LANGUAGES
Experience in Quality, Manufacturing or Engineering roles preferred.
Audit experience is preferred.
Combination products (medical devices / pharmaceutical) experience desirable.
Experience working in an internal audit program is preferred.
Good written and oral communication skills as well as report writing, presentation and training skills.
Accomplish objectives in a timely manner without day to day supervision.
Good interpersonal skills; customer service oriented.
Knowledge of 21CFR Part 4 & 820, ISO 13485, MDD/MDR, CMDR, TGA, JPAL and ANVISA Regulations preferred.
Knowledge of Good Manufacturing Practices (GMPs), Data Integrity principles and Quality System Regulations (QSRs) preferred.
Training in Process Excellence/Six Sigma tools and methodologies and Certification preferred.
Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification is preferred or the ability to become certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification within 1 year is required.
Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required. Experience with Microsoft Project is preferred.
Experience in leading and managing projects and milestones preferred.
Experience with Minitab is preferred.
Statistical and analytical problem solving is preferred.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Texas-San Angelo
Ethicon Inc. (6045)