Quality Assurance Engineer II
DSM 60 reviews - Exton, PA

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Assure that DSM products are of consistent and high quality by: maintaining and assisting in the operation and development of the QA/QC functions for DSM in compliance with GMP, ISO, Canadian and other required standards

The Challenge
  • Develop, document, and implement QA Procedures
  • Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
  • Create suitable data analysis tables and report findings based on statistical evidence and trending.
  • Provide analytical investigations and develop root cause for non-conformances and deviations
  • Design and specify gauging and test equipment for quality assurance functions
  • Analyze data and generate summary reports
  • Interface with vendors and customers as required
  • Write validation protocols
  • Review documentation for completeness and accuracy
  • Assist in the performance of qualification and validation studies
  • Create and/or process XCN’s, ECN’s, process routers, drawings and other written documentation in accordance with GMP requirements to support product development and manufacturing.
  • Assist with product development and in the transition of development products and projects.
  • Supervise technicians and interns.
  • Complete other tasks as assigned.

The Ideal
  • 2 - 6 years progressive experience in the development of biomaterial-based medical products or a related industry.
  • Bachelors or Master’s degree in Engineering: Biomedical, Mechanical, Chemical, Materials, Biology or related field.
  • Good written and oral communications skills
  • Ability to lead and/or function as part of a team.
  • Computer literacy (ie - Word, Excel, PowerPoint, Project, WindChill)
  • Understanding of GMP and standards.
  • Knowledge of medically useful biomaterials (degradable and non-degradable)
  • Knowledge of physical and chemical processing techniques. (ie- melt processing, compression molding, foaming, lyophilization, aseptic processing, cross-linking, sterilization)
  • Working knowledge of analytical and mechanical test equipment.
  • Experience using Minitab would be beneficial.

The Procedure and Contact Please apply online and send your resume and cover letter in English and include information on your current remuneration.

Please submit application before deadline: 12/31/2013

About this company
60 reviews
DSM wants to get more out of life, or at least life and material sciences. It focuses on nutritional products and performance materials,...