Johnson & Johnson Careers
Primary Quality Engineer
Requisition ID: 6643191003
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Primary Quality Engineer located in Cincinnati, OH.
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.
- Developing, executing, and documenting Process Qualification (IQ, OQ, PQ) manufacturing processes
- Ongoing training of existing policies and procedures
- Develop measurement systems (MSA) to monitor effectiveness of QA and reliability.
- Support of steady state manufacturing in accordance with defined QA program for product improvement or transfer
- Provide statistical support for manufacturing and product development.
- Perform CAPA and NC activities such as root cause analysis, risk analysis, identify sources of variation, continuous improvement, and effectiveness monitoring.
- Assess and approve verification and validation activities
- Support development of product and process validation strategies.
- Create/Review/Approve Ethicon Endo Surgery and Torax documentation related to product/process quality characteristics. (Design/Manufacturing Specifications, FMEAs, Inspections, Product Inquiries, Process Capability, Product Requirements, Sampling Plans, Change Management, CAPA, and Non-conformances)
- Support current production manufacturing processes, change control, signal detection/escalation
- Support in technical issues for manufacturing processes that are to be transferred to satellite facilities.
- Support statistical and analytical problem solving for design and manufacturing applications.
- Support Regulatory Affairs department to perform review of engineering changes / modifications to products / and other regulatory requests.
- Generally, operate independently with moderate direction and mentor support.
- Contributing to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
- Support product complaint inquiries, product escalations, and returned device analysis as required.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned
- A minimum of a Bachelor’s degree is required. Engineering degree is preferred.
- Experience with Quality Engineering/Scientific methods and techniques required.
- A minimum of 2 years of work experience is required.
- Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.
- Experience working with Good Manufacturing Practices (GMPs) and ISO policy and procedures preferred.
- Product change process experience is preferred.
- Experience supporting the development of test methods in equipment, process, and product qualifications/validations preferred.
- Experience supporting production and process controls using proven techniques (for example, process capability measures, statistical process controls, and process performance metrics) is preferred.
- Experience performing or guiding Measurement Systems Analysis (MSA) is preferred.
- Fundamental technical understanding of manufacturing equipment and processes is preferred.
- Experience with any of the following is a plus: Technical Protocol and Report writing, Statistics,
- Microsoft Office, Reliability, CAPA Problem-solving, Nonconformance (NC) investigation process, Gage repeatability and reproducibility, Minitab and Process qualification (IQ, OQ,PQ) knowledge.
- Regulatory compliance knowledge with the following is a plus: GMP, MDD (Medical Device Directive), 510K (Pre-market Notification), ISO 13485, ISO 14971
- This position will be in Cincinnati, OH and will require 30% travel with potential for additional travel beyond this depending on business needs.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Torax Medical, Inc (6251)