Staff Quality Engineer - New Product Development-3009140821
Description
DePuy Synthes, Inc., a Johnson & Johnson Company, is currently recruiting for a Staff Quality Engineer - New Product Development, located in West Chester, PA.
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
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 Staff Quality Engineer - New Product Development represents the Quality Engineering function on product development teams supporting activities during various stages of a product’s life cycle. This individual ensures that either new product development or sustaining engineering projects are conducted in compliance with internal, customer, and regulatory requirements.
This individual will work in a design team setting. This individual will support design control activities for new product development efforts, including design transfer. He/she will develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans.
The Staff Quality Engineer - New Product Development will provide leadership in the understanding of medical device regulations to other disciplines. He/she 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.
The Staff Quality Engineer participates in component and service supplier evaluation, including supplier audits, if applicable. This individual works with suppliers to ensure appropriate quality controls are implemented. The individual in this position will be expected to review lot documentation and release product for clinical use, as well as taking leadership in audits of Design History Files. This individual guides product development teams on efficient and effective application of design controls. Drive the successful deployment of the Design Excellence methodology into NPD process by providing technical support, ongoing improvement of global processes and mentoring of black belts in training.
Qualifications
To be considered for the role a minimum of a Bachelor Degree in an Engineering or Scientific discipline is required. An Advanced Degree in a related field is an asset. A minimum of 7 years’ experience in a GMP and/or ISO regulated industry is required. Medical Device and/or Pharmaceutical industry experience is preferred. Knowledge of ISO 14971 (including risk evaluation techniques, such as FMEA or fault tree analysis), FDA Quality System Regulation, ISO 13485, and the EU Medical Device Directive is an asset. Quality engineering experience is preferred. Experience conducting Process/Design Failure Mode Effects and Analysis is an asset. Mechanical product knowledge is preferred. Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and sampling techniques as well as a proficiency in test method validation is an asset. Experience with test plan development and root cause failure analysis is required. The ability to apply statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, design of experiments and reliability demonstration are preferred. Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required. Process Excellence/Lean experience is preferred. Experience applying Design Excellence from concept to full implementation in a technical / R&D setting. A Certified Black Belt in Six Sigma, Design Excellence achieved through a recognized industry practitioner is required.
This position will be based in West Chester, PA and will require 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
J2W:DICE
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Travel:Yes, 10 % of the Time
Job Function: Quality (Eng)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement