Johnson & Johnson Careers
Senior Design Quality Engineer
Requisition ID: 4951190121
DePuy Synthes is recruiting for a Senior Design Quality Engineer in Warsaw, IN.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
As the Senior Design Quality Engineer, you will apply intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
The Senior Design Quality Engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. You should be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
Your responsibilities will include, but are not limited to:
- Core team member of new product launch team working with product development, marketing, and manufacturing.
- Interacts with suppliers or internal manufacturing on production of implants or instruments. Coordinates and facilitates process verification/process validation activities for suppliers.
- Demonstrates proficiency in applying 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.
- Demonstrates proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, and effects analysis).
- Conducts or contributes to the reliability assessments of product design.
- Contributes to root cause investigations using various problem solving techniques and tools, and assesses effectiveness of corrective actions.
- Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.
- Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.
- Implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, process performance metrics).
- Participates in technical reviews as appropriate.
- Supports execution of strategic vision or plan by collaborating with other quality leaders to identify required Quality Engineering skills and competencies.
A minimum of a Bachelor's degree or equivalent degree is required preferably within Engineering, Technical, or Scientific discipline. An Advanced degree in a related field is an asset.
- A minimum of 4 years of experience is required, preferably within a highly regulated environment (e.g. FDA regulated).
- Intermediate knowledge of Quality Engineering/Scientific methods and techniques are required.
- Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred.
- Quality Engineering/Design or Process Excellence/Lean experience is an asset.
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Fundamental technical understanding of manufacturing equipment and processes is required.
- Expertise in measuring techniques (for example mechanical, optical, gages, automation) required.
- Experience managing projects and demonstrating project leadership abilities is strongly preferred.
- You should have the ability to work independently and partner with a multi-functional team.
- Problem solving techniques including root cause analysis and cause and effect analysis are all preferred.
- Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
- ASQ certifications are an asset.
- This role is located in Warsaw, IN and may require up to 20% travel, including domestic and international.
Depuy Orthopaedics. Inc. (6029)