Johnson & Johnson Careers
Senior Quality Engineer – Lifecycle/New Product Development (1 of 2)
Requisition ID: 8403181128
Ethicon, Inc. is recruiting for a Senior Quality Engineer - Lifecycle/New Product Development located in Cincinnati, OH.
Quality Engineers are responsible for support and leadership of Quality Engineering activities in Life Cycle Engineering, New Product Development, CAPA, and process improvement activities.
The Medical Devices sector of Johnson & Johnson represents more than 60 manufacturing sites and 26,000 employees who design, plan, source, deliver high-quality and cost-effective medical products to our customers around the globe each day. Work in new product introduction and the supply chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
As part of the Medical Devices sector, Ethicon brings people together from around the world to advance surgery and have life-changing impacts in healthcare. We offer healthcare professionals solutions that address the key challenges of today’s surgical procedures in order to optimize patient outcomes. Our devices offer the surgeon options for access, advanced energy, ligation, hernia repair and fixation, surgical stapling, uterine and pelvic surgery, wound closure, and biosurgery. We bring advanced devices to the world.
- Provide leadership in design & implementation of quality engineering to support entire product life cycle with focus on Quality Engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of various products.
- Apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process and business improvements.
- Operate independently and may mentor or coach less experienced QEs. The Senior Quality Engineer will have more advanced understanding of the expected output of quality processes and be able to assess the adequacy of objective evidence.
- Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
- Provide review and approval for the release of new products and design changes ensuring quality requirements are met.
- Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
- Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
- Use analytical problem-solving skills to contribute in root cause investigations and can assess effectiveness of corrective actions.
- Use sound statistical applications in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
- A BS in Engineering from an accredited engineering or relevant science/technical school is required; an Advanced Degree is preferred.
- A minimum of 4 years of work experience, preferable in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience is required.
- Intermediate knowledge of Quality Engineering/Scientific methods and techniques is required.
- Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) required.
- Test method development, statistics and reliability required.
- Experience working within a team, obtaining feedback, negotiating and training required.
- Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment required.
- Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) required.
- Understand new concepts quickly, research and maintain ongoing learning of industry regulations required.
- Fundamental technical understanding of manufacturing equipment and processes required.
- Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) is preferred.
- Knowledge of: Regulatory compliance, GMPs, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications desired.
- 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.
- Ability to lift boxes up to 20 pounds, office desk work requiring sitting, walking, reaching, stooping, bending, using phone, keyboard/computer and ability to focus for extended periods of time on detailed work
- This position is located in Cincinnati, OH and has up to 10% of both 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)