Ethicon, a member of Johnson & Johnson's Family of Companies is currently recruiting for a Senior Quality Engineer for our Cornelia, Georgia site.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com (http://www.ethicon.com/).

JOB SUMMARY
Provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards.

DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

1. Will own the Non-Conformance Report (NCR) process and system which includes representation of our sites on the worldwide NCR team.

2. Responsible for the data analysis, reporting and identifying quality issues. Responsible for reporting NCR scorecard results to appropriate sites management.

3. Identify quality issues for immediate resolution and work effectively with CAPA site leaders to ensure that these are raised to CAPA accordingly.

4. Provide education and mentoring as needed regarding NCR process and applications to site. Serve as SME and administrator for all sites in the electronic process system for NCR.

5. Establish and report NC dashboard/metric against base business performance to management.

6. Develop and implement measures to supervise the efficiency of the NCR process.

7. Lead in quality system and compliance improvements that result from Internal/External Audits, management Reviews or NCR/CAPA system indicators.

8. Provide support to CAPA leader in the preparation of Data Review Board, CAPA and the administration of the system.

9. Support all internal external audit or assessment to the sites.

10. Lead the QA Hold restrict Area. Assure that identification and traceability of product in restrict disposition are in compliance with current procedures.

11. Coordinates available resources to achieve a reliable, efficient and productive operation. Using a detailed familiarity with the requirements of US regulations for the manufacture of medical devices, the ISO standard (ISO 13485), and the EC Medical Device Directive, provide compliance education in support of overall informative strategies.

12. Responsible for presenting business related issues or opportunities to next management level.

Qualifications

1. Bachelor’s degree is required. Concentration in Engineering and/or Scientific subject area preferred.

2. Five years of broad-based expertise in Quality System Regulations.

3. CAPA, Complaints, Quality Operation, Change Management.

4. Expertise and solid understanding of Medical Device Regulations.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (http://www.careers.jnj.com/).

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.