Posted: Friday, September 8, 2017 9:54 PM
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, Life Cycle Quality Engineering, 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 effectiveness 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.
The Life Cycle Quality Engineering Manager is responsible for leading the Life Cycle Engineering group in support of New Product Development, CAPA, Design Change Control, Product Quality, and process improvement activities. The team is leading the continuous improvement of quality systems to facilitate business and quality objectives.
Key responsibilities of the Manager, Life Cycle Quality Engineering include but at not limited to the following.
- Provide leadership in design & implementation of world-class quality systems to support the entire product life cycle with focus on business results including reduced cycle time, lower COGS (Cost of Goods Sold), prevention, detection of defects at earliest phase of product design, continuous improvement, and customer satisfaction.
- Provide leadership, technical expertise & improvements in design, development & deployment of Quality & Reliability Engineering (tools & systems), ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems, developing business metrics & analytical problem solving through sound statistical application.
- Provide review and approval for the release of new products ensuring quality requirements are met, including design verification and validation, process validation, stability testing, risk management, design transfer, and design review.
- Provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence, and lean thinking. Direct development & consistent application of quality policies & procedures in product design & development, secondary development, and transfer operations. Provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking. Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
- Lead & manage Quality Engineers to implement EES and QSRC strategies & objectives. Build organization's capability & leading engineers to build effective quality engineering processes at all levels. Guide high-level engineers such as Staff, Principal QE in development & deployment of innovative Quality Engineering tools, techniques & systems that will drive product development to successfully achieve key business results. Lead cross-divisional relationships. Participate in & support audits with FDA and other regulatory agencies.
- A minimum of a Bachelor Degree is required with a preference in engineering, applied sciences, or equivalent. An advanced degree & certifications are preferred i.e.â CQE (Quality Engineer Certification), CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification), CQM (Certified Quality Manager), Certified ISO (International Organization for Standardization) Auditor.
- Key skills and knowledge that are important in order for you to be successful include the following: Management skills, Interpersonal skills, Organizational Leadership, Regulatory Compliance knowledge, excellent verbal and written communication, Product Knowledge, Statistical Knowledge & Application, Ethics, Quality Engineering, and the Ethicon Development Process are preferred.
- Training, Process Excellence (DMAIIC, DMADVV, and Lean), Analytical - solving problems, Achieving objectives, Initiative - innovative ways to quality engineering and quality systems, Decision-making - using all available information, Influencing - bringing cross-functional & cross level people to consensus are preferred.
- A minimum of 5 years of experience is required, preferably in developing & implementing systems in a regulated industry to ensure product and process quality. Experience in medical device industry is preferred. Previous supervisory experience in quality engineering or quality assurance is preferred. Lifecycle experience is preferred.
- This position requires up to 10% domestic and international travel.
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)
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=9742170905&lang=en
• Location: Cincinnati
• Post ID: 49053267 cincinnati