Johnson & Johnson Careers

Design Quality Engineer II

Raynham, Massachusetts
Quality (Eng)

Job Description

Requisition ID: 4452180226

DePuy Synthes Mitek Sports Medicine is currently recruiting for a Design Quality Engineer II 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 II 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/Lead process validation strategies (inclusive of IQ/OQ/PQ) based on relationship to design controls, CAPA, NC, etc.
  • Conduct/Lead Test Method Validation and Product Verification Testing
  • Support and lead 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.

  • A minimum BS degree in a technical discipline is required.  An advanced degrees is a plus
  • A minimum of 2 years of direct and/or related engineering work experience in a regulated environment is required
  • Strong engineering skills with a proven track record in process validation and failure mode effects and analysis is also required.
  • Working knowledge of the QSR Part 820 and ISO 13485 & 14971 quality requirements is preferred.
  • Knowledge of Six Sigma Process Excellence tools is preferred. 
  • Excellent problem solving and decision making skills is required.
  • 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. 
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 & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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