Johnson & Johnson Careers
Staff Quality Engineer
Requisition ID: 1143180510
Medical Devices & Diagnostics Global Services, LLC, a division of Johnson & Johnson Family of Companies is recruiting for a Staff Quality Engineer to be located in Raynham, MA.
Medical Devices & Diagnostics Global Services, LLC., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D 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.
Johnson & Johnson has agreed to sell the Codman Neurosurgery (CNS) business to Integra LifeSciences subject to customary closing conditions and regulatory approvals. Please be advised that should you be hired, upon completion of this transition, your employment and the position with Codman Neurosurgery will transfer to Integra LifeSciences.
The Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The staff engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods
The Staff Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business and supervise or lead technicians.
Major Responsibilities & Duties:
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Conduct benchmarking to develop more effective methods for improving quality and compliance.
- Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
- Champions compliance of product and processes to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Support Quality System Metrics as applicable.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for Quality technicians
- Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
- Ensures effective quality strategies are created for the validation, production, risk assessment, and investigation.
- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
- Minimum 5 years of related experience required.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
- The ability to perform "hands on" troubleshooting and problem solving is required.
- The ability to think on the feet and providing sound judgment is highly desired.
- Good technical understanding of manufacturing equipment and processes is preferred.
- Understanding of Process Validation is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- Strong mentoring, coaching and leadership skills are required.
- Advanced knowledge and proven leadership in the areas listed in the Duties and Responsibilities associated with the position.
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.
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