Johnson & Johnson Careers
San Angelo, Texas
Requisition ID: 8094190621
Ethicon Surgical care, a member of Johnson & Johnson's Family of Companies is recruiting for a Compliance Engineer, located in San Angelo, Texas.
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,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 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
- 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;
- Craft reports and communicate performance against metrics to key partners.
- 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 relevant review.
- Follow all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001)
- Other tasks;
- 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
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
- 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
- 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 required.
- Accomplish objectives in a timely manner without day to day supervision required.
- Good interpersonal skills; customer service oriented required.
- 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.
- 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.
- This role is located in San Angelo, TX and may require up to 10% travel.
United States-Texas-San Angelo-
Ethicon Inc. (6045)