Senior Quality Assurance Engineer - Newark, Delaware United States - 21111

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JOB DESCRIPTION

Job #: 21111
Title: Senior Quality Assurance Engineer
Job Location: Newark, Delaware - United States
Employment Type:
Salary: $90,000.00 - $115,000.00 - US Dollars - Yearly
Other Compensation: bonus, benefits and other compensation
Employer Will Recruit From: Nationwide
us Citizen, green card holder
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


Senior Quality Engineer (Medical Device), Newark, DE

Growing & Profitable $3B Medical Device Manufacturer seeking talented Senior Quality Assurance Engineer for one of their large manufacturing sites.  This position will provide quality assurance leaderships/support to the implementation, maintenance, and improvement of the Quality Management System.  Provide quality assurance support to the compilation, analysis, and presentation of post-market Quality data, including Management Review, Risk Management Board, Complaint Review, NCR Reviews, and Supplier Quality Performance review.  Activities include: process changes, CAPA programs, Supplier Management, Internal Audits (ISO 13485:2016) QSR, internal audit responses, post-market Quality data, etc. 

Great work environment!

Opportunities for growth and advancement!

JOB DESCRIPTION

Growing & Profitable $3B Medical Device Manufacturer seeking talented Senior Quality Assurance Engineer for one of their large manufacturing sites.  This position will provide quality assurance leaderships/support to the implementation, maintenance, and improvement of the Quality Management System.  Provide quality assurance support to the compilation, analysis, and presentation of post-market Quality data, including Management Review, Risk Management Board, Complaint Review, NCR Reviews, and Supplier Quality Performance review.  Activities include: process changes, CAPA programs, Supplier Management, Internal Audits (ISO 13485:2016) QSR, internal audit responses, post-market Quality data, etc. 

Great work environment!

Opportunities for growth and advancement!

QUALIFICATIONS

  • BS degree in an Engineering
  • Must have 5+ years developing, managing, executing, and improving Quality Management Systems in the medical device/pharmaceutical industry.
  • Experience with design, development and implementation of complaint QMS documents
  • Experience managing & execution of CAPAs and the CAPA system
  • Supplier Management process, managing and executing of internal audits
  • Trending, analyzing and reporting Quality data
  • Certified Lead/internal auditor to ISO 13485
  • Managing, executing and improving process in QMS
  • Experience in Agile or equivalent, software analysis tools
  • Detailed oriented & collaborative mindset

Education:
University - Bachelor's Degree/3-4 Year Degree