Process Quality Leader Quality Control

Ethicon, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Process Quality Leader Quality Control located in Cornelia, GA or Athens, GA. 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. JOB SUMMARY: Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards. DUTIES & RESPONSIBILITIES: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 1. Under the direction of the Business Unit Manager, the PQL provides technical leadership towards the Identification of the causes for non-conformances and process’ failures, and for the implementation of the remedial, corrective and preventative actions thus assuring process performance and compliance against Ethicon’s QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process. 2. Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement. 3. Provides guidance to manufacturing supervisors to ensure the effective in-depth investigations are performed. 4. Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same. 5. Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process. 6. Analysis of data and based on the trends recommends actions for process, equipment and system improvement. 7. Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems. 8. Provides training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements. 9. May lead a number of CAPA and should recommend CAPA’s based on negative trends. 10. Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB. 11. Leads in-process investigations with multifunction team to determine root causes and provides recommendations for corrections on preventive actions. 12. Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventative actions. 13. Provides technical supervision to multilevel, cross functional teams. Provides supervision to technical professionals such as College Recruits, Coops or Supervisors that are assigned to work on projects related to process enhancement initiatives. 14. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001). 15. Responsible for communicating business related issues or opportunities to next management level 16. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable 17. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures 18. Performs other duties assigned as needed Qualifications • Bachelor Degree in Engineering or Science is required. Master’s Degree preferred. • A minimum of six (6) years of experience in the QSR/ISO required-regulated medical device operation preferred. • Experience in a quality role within the manufacturing industry preferred. • Advanced computer skills (Microsoft Office) and use of software application (s) are required. • Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques. • Proficient in the preparation of technical reports and presentations. • Strong communication and interpersonal skills. • Requires good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates, in operations in the mainland. • Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills. • May requires working/visiting all three shifts of the operation and working irregular hours. • Will require sitting for extended periods of time, writing reports on the computer. • 10% of domestic and international travel my be required. Additional Position Requirements: 1. Work in team environment behaving in a CREDO based respectful manner. 2. Adhere to J&J environmental and safety policies and guidelines. 3. Comply with all job specific safety procedures and utilize PPE when necessary. 4. Comply with quality system requirements as defined within procedures and instructions. 5. Utilize applicable software systems as needed for the job (e.g. Compliance Wire, ADAPTIV, etc.) 6. Support LEAN and Six Sigma Initiatives. 7. Support Maintenance Excellence (ME2) including 6S and Operator Asset Care. 8. Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation). 9. Consistently meet required Training due date targets. 10. Develop and manage budgets to meet departmental goals and objectives. 11. Manage human resources to ensure qualified associates are given the opportunity and direction for growth, developmental, and promotional opportunities. 12. Ensure fair and consistent administration of policies in all actions pertaining to associates in area of responsibility. This includes proper communication, administration of attendance and discipline programs, and all company policies. 13. Active participant in forums to share knowledge and practices to ensure fairness, consistency, and simplification of processes. 14. Ensure processes followed to avoid non-valued added work and to foster good associate relations as identified in the CREDO. 15. Develop and support initiatives to implement World-Class Manufacturing standards (Process Excellence, Continuous Flow Manufacturing, and Statistical Process control). 16. Follow current compliance regulations and standards, such as, compliance with Good Manufacturing Practices based on business needs. Flexible to work other shifts as required. Seniority is not the determining factor in the utilization of shift assignments. 17. Partner with Engineering groups in: The design and development of equipment modifications, Conducting equipment process qualifications per written protocols, the development of written procedures for the operation, testing, and validation of equipment. 18. Ensure manufacturing associates are trained in the operation of production systems. Act as facilitator for new product development, customer driven process changes and World-class Business initiatives as required. 19. Utilize resources to ensure work area is maintained to high level of housekeeping standards. 20. Use Document Management System for accessing controlled documents. 21. Other miscellaneous duties and projects as assigned by supervisor. The duties of the position may change from time to time based on business needs. 22. Adhere to FDA quality and worldwide quality system and comply with all federal and state regulated programs. 23. Ensure safe working conditions and practices in the department. 24. Participate in recruiting activities and support EEO/AAP and diversity initiatives so that people of color and women are included in employment and promotional opportunities. 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. 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. Primary Location United States-Georgia-Cornelia-655 Ethicon Circle Other Locations North America-United States-Georgia-Athens Organization Ethicon Inc. (6045) Job Function Quality Requisition ID 2206065340W