Sr. Quality Systems Manager

Manage site-wide Quality Systems programs and team responsible for driving quality activity and compliance including managing audits, document control, NC/CAPA and post-market surveillance activity. 10+ years' experience in a regulated industry, preferably Medical Devices or Pharma.

This job is posted on behalf of Gallin Associates by Top Echelon.

CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATION

Manage site-wide Quality Systems programs and team responsible for driving quality activity and compliance including managing audits, document control, NC/CAPA and post-market surveillance activity.

REQUIREMENTS

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• Bachelor's degree in life sciences or related field preferred
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• 10+ years' experience in a regulated industry, preferably Medical Devices or Pharma
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• 5+ years in Quality or Regulatory Affairs
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• 3+ years managing staff
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• Experience with FDA Part 820, Part 1271, ISO 13485, or AATB standards
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• Experienced in supporting NC/CAPA and audit responses
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