Johnson & Johnson Careers
Design Quality Engineer II
Requisition ID: 1477180907
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.
You, the Design 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 degree 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.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification are also 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 will be based in Raynham, MA and will require 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 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.
Depuy Orthopaedics. Inc. (6029)