Job: Quality Engineer II

Jobing Description

Description

This individual will be responsible for effective and consistent quality systems. S(He) will support and provide guidance to the efforts and products manufactured at the Jaffrey, NH facility of EMD Millipore. To learn more about EMD Millipore s Jaffrey, NH facility, please visit www.millipore.com/jaffrey .

* Experienced Quality Engineer requires complete understanding and application of FDA GMP and ISO 9001:2008 principles, concepts and practices.
* Develops solutions to a variety of complex problems
* Designs, implements and continually evaluates quality assurance and/or control methods and systems.
* Designs methods and processes for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
* Conducts quality assurance tests, performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
* May conduct vendor visits to ensure quality.
* Develops standards and procedures to provide quality guidance and methods.

Qualifications

* Bachelors of Science degree in Biology, Pharmacy, Life Sciences, Quality, Engineering or related field.
* 3 years minimum in FDA regulated industry (pharmaceutical, biotechnology or medical device)
* ASQ Certified Quality Engineer (CQE)
* Minitab, Infinity QS SPC software (or statistical software equivalent) proficiency.
* Lean Six Sigma program/project implementation; green belt or black belt certification a plus.
* ASQ Certified Quality Auditor (CQA) or Pharmaceutical GMP Professional (CPGP) a plus
* This individual will have a positive, can do attitude and will be able to rally teams to drive towards a common goal. S(He) must have strong influencing skills with the ability to communicate across all levels and functions within the organization. The ability to gain consensus with groups is a must.
* Self-directed and self-motivated