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Senior Quality Engineer - New Product Development, Sports Medicine Job

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Location
USA-MA-Raynham

Profile

Raynham, MA, US
Senior Quality Engineer - New Product Development, Sports Medicine-0003121125
Description
DePuy Mitek has a newly created position for a Senior Quality Engineer - New Product Development in Raynham, Mass.
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.
DePuy Mitek is the Sports Medicine business offering orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.
In this newly created role supporting the New Product Development Quality Engineering group, the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated, must have excellent problem solving skills, and have excellent written and verbal communication skills.
The Senior Quality Engineer will be working in a design team setting, this individual will primarily support new product development projects of increasing complexity. He/she will provide leadership in all areas of the Quality System, including, but not limited to Design Controls, Risk Management, Corrective & Preventive Actions, Nonconforming Materials, etc. This individual will provide leadership in Design Excellence for product development team. The Senior Quality Engineer will provide sampling plans and approves inspection methods for evaluation and testing of components and products. He/she will provide leadership and expertise in developing clinically relevant test methods to evaluate new products. This individual will support and lead design control activities for new product development efforts. He/she will be asked to conduct and lead process/design failure mode effects and analysis as well as conduct and lead process validation activities. The Senior Quality Engineer will conduct internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements. Conduct audits of new suppliers as part of the project teams. He/she will provide leadership in the understanding of medical device regulations to other disciplines. This candidate must 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.
Working in a design team setting, the Senior Quality Engineer will primarily support new product development projects of increasing complexity. He/she will provide support in all areas of the Quality System, including, but not limited to Design Controls, Risk Management, Corrective & Preventive Actions, Nonconforming Materials, etc. This individual will provide support in Design Excellence for product development team. The Senior Quality Engineer will provide sampling plans and approves inspection methods for evaluation and testing of components and products. He/she will provide support and expertise in developing clinically relevant test methods to evaluate new products. This individual will support for design control activities for new product development efforts. The Senior Quality Engineer will support process/design failure mode effects and analysis. He/she will support process validation activities. This individual will assist with internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements. He/she will support audits of new suppliers as part of the project teams. The Senior Quality Engineer will provide support in the understanding of medical device regulations to other disciplines. This candidate must 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.
Qualifications
A minimum BS degree in an engineering or technical discipline is required. A minimum of 4 years of Quality Engineering is required. A Master's degree is preferred. A background in polymers or textiles is an asset. Candidate is required to 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. Strong quality engineering skills with a proven track record in clinically relevant test method development, design verification/validation, process verification/validation, and design/process failure modes and effects analyses is required. Design Excellence, Design for Six Sigma, Lean, or ASQ Certification an assets. Experience working in the medical device or healthcare industry is preferred. Medical product knowledge is preferred. Blueprint literacy including GD&T is preferred. Knowledge of the QSR and ISO quality requirements is preferred. This candidate should have a proven track record of developing and launching products that meet performance expectations and business goals. Proficiency with the Microsoft Office Suite is required.
This position will require up to 15% domestic and international travel. This position will be based in Raynham, MA and does not offer relocation benefits.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:
North America-United States-Massachusetts-Raynham
Organization:
DePuy Mitek, LLC (6028)
Travel:
Yes, 25% of the time

Company info

DePuy Companies
Website : http://www.depuy.com/

Company Profile
The Companies in the DePuy Family – DePuy Orthopaedics, Inc., DePuy Spine, Inc., DePuy Mitek, Inc., and Codman & Shurtleff, Inc. – have been pioneers in the fields of orthopaedics, spinal care, sports medicine and neuroscience therapies for decades. From non-surgical pain management to complete surgical solutions, our range of treatment options include those for treating or reconstructing damaged or diseased joints, caring for traumatic skeletal injuries, treating spinal disorders and deformity, and repairing injured soft tissue. We also offer a wide range of state-of-the-art therapies for neurological and central nervous system care.