Sr Quality Engineer
Medical Device Product Development
DE

Global leader in the development and production of life saving products seeks a Sr. Quality Engineer to help lead quality activities at the the company's manufacturing site in suburban NE Maryland near DE. This industry leader offers great career growth opportunities across its many divisions, both domestic and international. The Sr. Quality Engineer will:

Develop and administer quality initiatives, test methodologies and sampling plans for both products and processes
Participate and lead internal and supplier audits
Provide engineering support in the design, fabrication, development, installation, validation and qualification of equipment or product which could include feasibility studies
Assure overall regulatory compliance and quality systems standards, including CAPA

Job Requirements

Bachelors degree REQUIRED, preferably in engineering, quality or related scientific discipline
3+ years experience in quality engineering, in medical devices manufacturing
One year of audit experience preferred
Strong math skills, including statistics
ASQ,CQE certification preferred
Working knowledge of ISO 13485, MDD and CMDR
Excellent analytical skills and the ability to prioritize and handle multiple projects in a highly charged, highly regulated manufacturing environment
Excellent communications and computer skills
Lean - Six Sigma experience or certification preferred

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