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Senior Design Quality Engineer
West Chester, Pennsylvania
Requisition ID: 0707180124
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Design Quality Engineer to be located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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, we are creating one organization that will be agile and better equipped in 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.
The Senior Design Quality Engineer will be supporting the New Product Development Quality Group for the Trauma/CMF business, the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, self-motivated to take action, and have excellent written and verbal communication skills.
Position duties & responsibilities:
- Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business.
- Lead design and development planning activities for new projects.
- Participate in all aspects of the creation and execution of functional/design requirements for new projects.
- Conduct formal technical design reviews throughout the phases of the product development process.
- Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
- Apply statistical methods and design excellence tools to design verification and validation activities.
- Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.
- Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes.
- Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.
- Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Manufacturing, Supply Chain, and Marketing.
- Work closely with suppliers on the qualification of new parts and processes supporting product development.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program related activities as denoted by your supervisor or our Chief Compliance Officer. Additional duties as assigned.
- A minimum of a Bachelor Degree in Engineering and/or in a Technical Science is required. A Master’s degree is a plus.
- 4+ years related working experience in a GMP and/or ISO regulated industry is required.
- Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management is required.
- Previous experience in a medical device or a healthcare discipline is strongly preferred.
- Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is strongly preferred.
- Blueprint literacy including GD&T preferred.
- Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.
- You should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
- You should have a proven track record implementing Quality System improvements to meet compliance and overall business goals.
- Proficiency with the Microsoft Office Suite is required.
- This position will be based in West Chester, PA and will require up to 10% travel, including potential international.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson&JohnsonFamilyofCompaniesareequalopportunityemployers,andallqualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,color,religion,sex,sexualorientation,genderidentity,geneticinformation,nationalorigin,protectedveteranstatus,disabilitystatus,oranyothercharacteristicprotectedbylaw.
United States-Pennsylvania-West Chester
Depuy Orthopaedics. Inc. (6029)