Principal Compliance Engineer in Cornelia, Georgia | DiversityInc Careers
 

Principal Compliance Engineer


Ethicon, Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Principal Compliance Engineer, located in Cornelia, GA.   The Ethicon 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 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.   The Principal Compliance Engineer will ensure the execution of compliance activities, including the Internal Audit Program, to ensure a sustainable state of compliance to applicable regulations and standards including, but not limited to, 21 CFR 820, 21 CFR 4, ISO 13485/EN 1SO 13485, ISO 14971/EN ISO 14971, European Medical Devices Directive, European Medical Devices Regulations, Canadian Medical Devices Regulations SOR/98-282 and ANVISA (National Health Surveillance Agency Brazil) Technical Regulations of Good Manufacturing Practices (GMPs) of Medicinal Products and any other regulations or standards applicable to the site.  Support the external inspection and audit management of the site, which will include site inspection/audit readiness, execution and response activities.  Implement proactive compliance initiatives, as well as provide compliance guidance to the site, including compliance support for Quality improvement and remediation activities.  Serve on cross site and cross segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements.  Support in the management of internal and external audit observations to ensure identified gaps or systemic risks are identified and closed in a robust and timely manner.   Responsibilities will include:
  • Lead cross-functional teams to address systemic compliance risks.
  • Support external inspection readiness and associated activities.  Support site audit readiness activities to ensure inspection readiness at all time.
  • Support Internal Audit program and management execution.
  • Enterprise/Sector support.
  • Metrics collection and reporting.
  • Escalation of items in accordance with established procedures.
  • Implementation and adherence to external standards and regulations.
  • Provide input to and participate in Site Management Review and Quality Reviews.

Qualifications
  • A minimum of a Bachelor’s degree or equivalent is required, preferably in Engineering or a related technical field.
  • A minimum of 8 years of experience in a Food and Drug Administration (FDA) regulated industry (i.e. Pharmaceutical or Medical Devices) or another highly regulated industry is required.
  • Knowledge of ISO 13485 and 21 CFR 820 is required.
  • Experience leading internal Quality System audits required.
  • Experience in Compliance, Quality, Manufacturing or Engineering roles preferred.
  • Experience leading or managing an internal audit program is preferred.
  • Advanced computer and database management skills preferred.
  • Statistical and analytical problem-solving skills preferred.
  • Experience working with the FDA or BSI is preferred. 
  • Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification is preferred.
  • Must have excellent communication and interpersonal relation skills.
  • Must have proven leadership skills in associate involvement and teamwork.
  • Must have the ability to work under pressure achieving consistently high results in quality, efficiency, and compliance through individual and team efforts.
  • Must have the ability to analyze complex data and integrate multi-disciplinary feedback.
  • This position may require up to 15% domestic and international travel, with frequent travel to the Athens, GA plant.

 

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.


Primary Location
United States-Georgia-Cornelia-
Organization
Ethicon Inc. (6045)
Job Function
Quality (Eng)
Requisition ID
1534180907