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 Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The staff engineer is an emerging authority in a specific technical field, exercising considerable latitude in resolving technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods. The Staff Quality Engineer will apply tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle; use problem-solving skills to improve and maintain products/processes. They will apply appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise technicians. The Staff Engineer is also responsible for CAPA Site Lead for Cornelia and Athens. Responsibilities include facilitating operations of the CAPA System, ensures effective communication and training are deployed throughout the business. The CAPA site lead is responsible for leading site CAPA activities including: Administration of the CAPA systems, facilitation of the local data review board and management reviews, coordination and support of CAPA project teams, data trending and CAPA reporting and communication with management and team leaders. The CAPA Site Lead is an influential position within the Operations organization that employs effective communication, influencing, and interdependent partnering skills to get results and ensure the viability of the CAPA processes. DUTIES & RESPONSIBILITIES

• Support quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements.
• Review/analyze the efficiency of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Partners with R&D and other multi-functional partners to ensure the accurate application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer.
• Lead and maintain Material Review Board.
• Conduct investigations, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Approve IQ, OQ, PQ, TMV or Software Validation1. Bachelor's degree is required, with a degree in Engineering, Science or related field preferred.

2. Generally, requires (5-8) years related experience.
3. Minimum 5 years' experience in Operations, Engineering and/or Quality Assurance is required. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
4. Background in Medical Device Industry, preferred.
5. Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
6. Knowledge of regulatory requirements (ISO, QSR, etc.), preferred.
7. Process Excellence Green Belt Certification with proven problem-solving and statistics skills, preferred.
8. Proven project management skills with strong results orientation, required.
9. Understanding of the NPI process and Process Validation expertise is preferred.
10. A detailed understanding of GMP/ISO regulations and validation regulations is preferred. 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, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, 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. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. 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.

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