Design Quality Engineer I, Medical Device

Job description

Job Description

Requisition ID: 0622190329

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic 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, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we have created 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 Synthes Mitek Sports Medicine, develops, manufactures and markets creative solutions for a wide range of minimally invasive mobility therapies, including arthroscopic repair devices for knee, hip and shoulder pathologies.

DePuy Synthes Mitek Sports Medicine is currently recruiting for a Design Quality Engineer I located in Raynham, MA. This role provides Quality Engineering support to New Product Development specifically in the areas of Risk Analysis, Test Method Development and Validation, Design Transfer to Manufacturing, and Verification and Validation Strategies. The Quality Engineer I will:

·  Provide direction and oversight of the product development quality activities across assigned projects
·  Use basic statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc...)
·  Use risk assessment tools (e.g., ISO 14971, FMEA's, Product Maps, Inspection Plans, etc…)
·  Conduct process validation strategies based on relationship to design controls, CAPA, NC, etc...
·  Conduct/Lead Test Method Validation and Product Verification Testing
·  Support product Design Control activities for new product development efforts.
·  Support on-market design changes.
·  Conduct Procedure/Design Failure Mode Effects and Analysis.
·  Ensures that the product quality system entries are compliant, effective, and sustainable.
·  Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Sales, Supply Chain and Marketing in order to provide quality input.
·  Additional duties as assigned.

Desired profile

Qualifications

·  A minimum BS degree in a technical discipline is required. BS Engineering degree, preferred. An advanced degree is a plus.
·  1-2 years of direct and/or related work experience in a regulated environment is required.
·  Strong analytical skills with a consistent record is required.
·  Working knowledge of the QSR and ISO 13485 & 14971 quality requirements is preferred.
·  Knowledge of Six Sigma Process Excellence tools is preferred.
·  Interpersonal skills that foster conflict resolution as it relates to technical situations is required
·  This position is located in Raynham, MA and may require up to 10% travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Massachusetts-Raynham-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)
Requisition ID
0622190329