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Senior Quality Engineer
Requisition ID: 6771180321
Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer, Energy, located in Cincinnati, OH.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.
You, the Senior Quality Engineer will be responsible for:
- Providing New Product Team Support for quality system design and audit
- Lifecycle support of steady state manufacturing processes, change control, signal detection/escalation, and CAPA
- Conducting audits to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards and providing compliance assessment and status.
Other responsibilities of the Senior Quality Engineer will include:
- Maintain alertness to changes in the industry and regulatory environments and apply this information to business practices at EES
- Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA (Food and Drug Administration) requirement
- Prepare QA (Quality Assurance) system and assist in technical issues for manufacturing processes that are to be transferred to satellite facilities
- Manage established processes in support of steady state manufacturing in accordance with defined QA program for product transfers
- Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for manufacturing, technical services and product development Audit and approve manufacturing, quality, engineering and validation / qualification documents for conformance to ETHICON ENDO SURGERY business practices and departmental procedures
- Support development of validation strategy
- Act as liaison to Regulatory Affairs department to perform initial regulatory review of all engineering changes / modifications to products
- Perform analysis of documents / information to ensure that all critical product characteristics have been identified and properly evaluated
- Provide sampling plans and approve inspection, methods for evaluation and testing of components and products
- Provide support and expertise in reliability strategy and reliability growth demonstration during new product development.
The Senior Quality Engineer must maintain knowledge of and follow EES policies and procedures related to work activities performed in area of responsibility; complete training in area of responsibility within allowed time-period; training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures; complete required periodic re-training in areas such as safety and environmental; follow all company safety policies and other safety precautions within work area; promote safety to all associates that enter work area.
- A minimum of a bachelor’s degree is required. A degree in Mechanical, Electrical, Biomedical or other equivalent technical degree is preferred. An advanced degree is preferred.
- A minimum of 4 years of experience in medical device, pharma or another highly regulated industry is required.
- Knowledge of Regulatory compliance: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications is preferred. Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards is preferred.
- Experience with Risk Management (ISO 14971, MD QMS ISO 13485), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is preferred.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
- This position will be located in Cincinnati, OH and have up to 10% of both domestic and international travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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.
Ethicon Endo Surgery Inc (6041)