Quality Engineer, ADD, GMP, FDA, Medical Device, Bachelors, QA Job in York 17315, Pennsylvania US

Skills Required:

Quality Engineer, ADD, GMP, FDA, Medical Device, Bachelors, QA/QC, Documentation, Test plan,

Job Description:

Principal Quality Engineer – Medical Device/Drug Delivery, GMP, FDA
York, PA area
Direct Hire/Perm
Contact: Russ.Holland@cybercoders.com

We are currently seeking an experienced ( ideally 5+ years of experience), Degreed ( Bachelors in Manufacturing, Engineering), Quality Engineer to join our team, where we are developing cutting edge medical device and drug-delivery technology.

It will be your role to serve as GMP champion throughout the design and development process, performing risk analysis, overseeing the development of test methods/protocols, execution and support of verification efforts and providing support to the development teams through documentation and presentation of data.

The ideally qualified candidate will bring with them:

• EDUCATION: The candidate must have a degree in manufacturing engineering or mechanical engineering (Bachelors required, advanced degrees a plus).
• EXPERIENCE LEVEL: 3-5 years of experience (Target 7-10 years) as a quality engineer in the development of new medical products
• Being part of a small, dedicated, cross-functional development team
• Test method development and execution, including experience with metrology, GDT, and mechanical testing
• Experience with mechanical testing instrumentation (e.g. Instron, Zwick)
• Knowledge of transfer to manufacturing, manufacturing processes, medical device regulations, FDA submissions, testing, planning
• Strong preference for candidates from pharmaceutical and/or medical device industry with experience in the development of combination products

Must be authorized to work in the United States on a full-time basis for any employer.

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Russ.Holland@CyberCoders.com
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Russ Holland - Senior Recruiter - CyberCoders

CyberCoders, Inc is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.