US: Quality Engineer
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please visit http://sqa.fyicenter.com
* Responsible for all operational quality aspects associated with product manufacture and release.
* Responsible for the successful validation and qualification of process and raw material changes.
* Investigate Quality problems associated with the production department and implement effective corrective and preventive measures
* Drive/support & implement continuous improvement projects with the operations team using Process Excellence lean/six sigma tools.
* Ensures the pertinent corporate quality and regulatory standards are attained.
* Maintains strong communication with internal and external stakeholders.
* Participates / supports the Internal and External Audit Programme.
* Participate in teams to help make necessary improvements and changes to all process related issues in the production department
* Identify and implement continuous improvements in conjunction with the operations team.
* 3 years minimum in FDA regulated industry (pharmaceutical, biotechnology or medical device)
* 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
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI