QA Engineer II
Location: Highland Heights, OH
Duration: 12 months
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.