Johnson & Johnson Careers
STAFF QUALITY ENGINEER QRC ROBOTICS
Requisition ID: 4045190114
The Ethicon business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Staff Quality Engineer, QRC Robotics, located in Cincinnati, OH.
The Ethicon 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. 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. This is an opportunity for a key role in bringing exciting new products to market to support the J&J / Google robotics venture. Ground-floor position to help grow and build a new J&J business unit, enabling significant professional growth.
You, the Staff Quality Engineer will be responsible for support and leadership of Quality Engineering activities in New Product Development/ Process Introduction and Lifecycle/Business Improvement activities.
• Develop Quality Agreements with suppliers and global partners.
• Apply knowledge of external standards and regulations to develop compliant Quality System strategies (for example: PMS (Post Market Surveillance), Complaint strategies, and Supplier strategies).
• Conducting audits to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards and providing compliance assessment and status.
• Support internal and external audits for Ethicon and partners. Ownership of audit observation and timely closure of identified issues.
• Support Verification and Validation strategies for new product development
• Providing New Product Team support for quality system design and audit by ensuring compliance to local, national and international regulatory standards, company policies and procedures.
• Direct development & consistent application of quality policies & procedures in product design & development.
• Stabilizing new product launches through steady-state manufacturing processes, change control, signal detection/escalation. Drive compliant strategy for post market surveillance and identification of processes and resources to execute.
• Apply advanced Quality Engineering/Scientific Method techniques/Six Sigma/Lean/ and Quality Tools to project tasks deliverables. Must have strong understanding of statistical methods and experience applying in product development and manufacturing processes
• 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.
• 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.
The Staff 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.
• Ensure compliant QA (Quality Assurance) system for manufacturing processes that are to be transferred to satellite facilities
• Ensure compliant design controls for development of product requirements, and design verification and validation strategy
• Act as liaison to Regulatory Affairs department to perform initial regulatory review of all engineering changes / modifications to products
• 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 BS in engineering from an accredited engineering or relevant science / technical school is required.
- A minimum of 6 years of related work experience is expected.
- Experience in a regulated industry (medical device) is required.
- Experience with medical electrical-mechanical systems an asset.
- Experience with human factors and clinical design validation is preferred.
- Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is required.
- Advanced knowledge of Quality Engineering/Scientific methods and techniques is as asset.
- Applied statistics of increasing complexity is an asset.
- 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, required
- Previous work experience engaging in a team-based environment is required.
- Must have ability to asses that process Quality control plans and Quality procedures are being followed in accordance with product or process risk level
- Knowledge and understanding of statistical techniques such as capability measures, statistical process controls, process performance metrics, MSA, and test methods is an asset.
- Certified Quality Auditor from ASQ, 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.
- Must have understanding of configuration management processes, including planning, configuration identification, configuration control, change management, status accounting, auditing and reporting.
- This position will be located in Cincinnati, OH
- Moderate domestic and international travel of up to 25%
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)