Quality Systems Lead
Job Description
Ethicon, a member of Johnson & Johnson's Family of Companies is recruiting a Quality Systems Lead to be located at Cornelia, Georgia.
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/).
The Quality Systems Lead manage all aspects of the day-to-day operations of the Quality Systems staff, coordinates the development and implementation of processes, procedures, audits and corrective actions, and ensures effective communication and training are deployed throughout the business.
The Quality Systems Lead is responsible for the overall management and effectiveness of the site Document Control, Records Control, Quality System Management Review (QSMR), and Non-conforming Reporting (NCR) and Corrective and Preventive Action (CAPA) programs including: Administration of the Document/Change Control, Records Control, QSMR, NCR and CAPA systems, facilitation of the local CAPA review board and other Quality system reviews, and is responsible for the coordination, collection and reporting of Quality system metrics including reporting status to management and supporting internal and external QMS audits.
Key Responsibilities
• Lead the Document/Change Control, Records Control, QSMR, NCR and CAPA processes and systems for the sites.
• Leads the implementation and administration of Quality Management Systems in accordance with applicable standards.
• Requests data and metrics reports obtained from quality databases for inclusion in management reports. May be required to analyze or interpret data for reviews.
• Examines results from management reviews, third party inspections and internal audits and approves proposed corrective actions.
• Work effectively with other Quality System site leaders to ensure consistent systems and processes at Ethicon plants.
• Provide education and guidance regarding Document/Change Control, Records, NCR and CAPA and general Quality system requirements.
• Develop and implement measures to monitor the effectiveness of the NCR and CAPA systems.
• Lead quality systems and compliance improvement, which result from Internal/External Audits, Management Review and/or any other CAPA/NCR system indicator.
• Coordinates the complaint product evaluations activities for the site and maintains track and trending of product performance/results of product evaluations for CAPA.
• Responsible for presenting business-related issues or opportunities to next management level.
• Responsible for facilitating and owning the Quality System Management Reviews for Athens and Cornelia.
• Bachelor’s degree is required, with a degree in Engineering, Science or related field preferred. Advanced degree is preferred.
Experience and Skills:
Required
• Minimum 8 years related experience in Operations, Engineering and/or Quality Assurance
• Background in Medical Device/Pharma Industry
• Experience leading NCRs, CAPAs and Failure and Root Cause investigations
• Strong communication, influencing, and presentation skills
• Ability to train, negotiate, and make decisions to improve overall culture of awareness and drive compliance and continuous improvement.
Preferred
• Green Belt Certification with demonstrated problem solving skills
Other:
• This position may require up to 10% of domestic and/or international travel.
• This position will be primarily located in Cornelia, GA but will also require onsite support in the Athens, GA facility as needed.
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.
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.
Primary Location
NA-US-Georgia-Cornelia
Other Locations
NA-US-Georgia-Athens
Organization
Ethicon Inc. (6045)
Relocation Eligible
Yes - Within Country
Travel
Yes, 10 % of the Time
Job Function
Quality Systems
Job Qualifications
Education:
Hospitals and Health Care
Quality Assurance
Full-time