Job Information
J&J Family of Companies Quality Engineer I in Raynham, Massachusetts
Quality Engineer I - 2406201483W
Description
Johnson & Johnson Medical Device a member of the Johnson & Johnson Family of Companies is currently recruiting for a Quality Engineer ! This position will be located in Raynham, MA.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
The Quality Engineer I should excel in an environment that embraces teamwork, change, risk-based decision-making, and flexibility. This individual will work in a design team setting. This individual will support design control activities for new product development. They will also support quality deliverables and tasks for commercialized devices on an as required basis.
Key Responsibilities:
This person will also be responsible for developing risk assessment, inspection methodology and acceptance criteria for inspection sample plans.
Work with and lead conversations with suppliers to qualify manufacturing processes as a part of design transfer activities.
He/she will provide leadership in the understanding of medical device regulations to other disciplines. The Quality Engineer I will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, Medical Affairs and Marketing.
This role will also be responsible for activities related to maintaining safe and effective product in the field including but not limited to design changes, supplier transfers, DHF remediation, risk benefit analysis development, test method development and investigations related to non-conformances, CAPA or audit observations.
Qualifications
Education:
A minimum of a Bachelor’s or equivalent University degree is required, recent graduates will still be considered.
Preferred:
1 year (work, internship, co-op, etc.) experience.
Quality Engineering/Process Excellence/Lean experience.
Experience/Familiarity with manufacturing process capability/use of minitab.
Experience conducting Process/Design Failure Mode Effects and Analysis.
Mechanical product knowledge.
Experience with Blueprint reading/literacy including GD&T
Familiarity with inspection methods and techniques.
Knowledge of the QSR, Design Controls, and ISO quality requirements.
Excellent problem solving, decision-making skills and Interpersonal skills that foster conflict resolution as it relates to technical situations are desired.
Other:
This position may require up to 10% domestic 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 NA-US-Massachusetts-Raynham
Organization Medical Device Business Services, Inc (6029)
Travel Yes, 10 % of the Time
Job Function R&D/Scientific Quality
Req ID: 2406201483W
J&J Family of Companies
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