Johnson & Johnson Careers
Senior Quality Engineer, New Product Development
Requisition ID: 3597181003
The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care 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 electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
You, the Senior Quality Engineer will be responsible for support and leadership of Quality Engineering activities in New Product Development/ Process Introduction and Lifecycle/Business Improvement activities.
- Drive Verification and Validation strategies for new product development
- Providing New Product Team support for quality system design and audit
- Stabilizing new product launches through steady-state manufacturing processes, change control, signal detection/escalation
- Conducting audits to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards and providing compliance assessment and status.
- Launch and stabilize new product launches through concept, design, development, and steady-state processes.
- Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Support quality engineering activities in development and maintenance of software for medical electrical systems.
- Provide review and approval for the release of new products ensuring quality requirements are met provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking.
- Direct development & consistent application of quality policies & procedures in product design & development
- Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
- Proactively engage stakeholders to drive consensus and resolve issues in a timely fashion.
- Resolve internal and external sources of requirements (e.g. regulatory standards, risk management processes).
The Senior Quality Engineer additional responsibilities may include:
- Maintain alertness to changes in the industry and regulatory environments and apply this information to business practices at EES
- 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 business practices and departmental procedures
- Support development of product requirements, and design 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
- • Develop inspection and sampling plans, test methods, and transfer functions for components and products
- Provide support and expertise in developing and executing a reliability strategy during new product development.
- Apply advanced Quality Engineering/Scientific Method techniques/Six Sigma/Lean/ and Quality Tools to project tasks deliverables.
- Plans and conducts projects and assignments with technical responsibility and strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders
- Generally, operate more independently and may mentor or coach less experienced QEs.
- Contributing to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions.
- A minimum of 4 years of related work experience is expected. Experience in a regulated industry (medical device) is preferred. Experience with medical electrical-mechanical systems an asset.
- Experience with human factors and clinical design validation required.
- Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
- Advanced knowledge of Quality Engineering/Scientific methods and techniques. Applied statistics of increasing complexity is required.
- New product development experience is required.
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment, strongly preferred.
- Previous work experience engaging in a team-based environment is required.
- Assist teams in developing robust requirements traceable to customer requirements and in identifying critical-to-quality product and process elements is preferred.
- Conducting or contributing to the reliability assessments of product design is preferred.
- Conducting and supporting the development of test methods in equipment, process, and product qualifications/validations is preferred.
- Ensuring that process Quality control plans and Quality procedures are in accordance with product or process risk level and are consistently followed is preferred.
- Knowledge and understanding of statistical techniques such as capability measures, statistical process controls, process performance metrics, MSA, and test methods. (Req)
- Certified Quality Engineer from ASQ and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred.
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.
- Prior software quality engineering experience in a product development environment is an asset.
- Must have a basic understanding of configuration management processes, including planning, configuration identification, configuration control, change management, status accounting, auditing and reporting.
- Fundamental technical understanding of manufacturing equipment and processes is preferred.
- This position will be located in Cincinnati, OH
- Moderate domestic and international travel of up to 25%
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 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.
Ethicon Endo Surgery Inc (6041)