QA Engineer II

QA Engineer II
Location: Highland Heights, OH
Duration: 12 months
 
Description:
 
MUST HAVE - 4 year degree, preferably in Life Sciences 
MUST HAVE - Knowledge and experience in Medical Device Regulations or Pharmaceutical Regulations 
 
Experience: 3-5 years professional experience. Education: Bachelor's Degree or equivalent unless otherwise specified. 
• Ensures compliant and effective QMS maintained. 
• Accountable for the transformation of all current QMS’s parts in scope towards the single PQMS structure. 
• Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope. 
• Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope. 
• Ensures Q&R requirements are effective in all processes in scope. 
• Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration established within scope.

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