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Quality Assurance Lead

2 months ago

Nashua, New Hampshire, United States BioTalent Full time

Overview

BioTalent is collaborating with a prominent manufacturer in the medical device sector, looking for a Quality Assurance Manager to enhance their operational excellence. This role involves critical oversight of essential documentation to ensure compliance and operational integrity.

Key Responsibilities

  • Evaluate and authorize key documents such as Device History Records, Standard Operating Procedures (SOPs), Validation Protocols, Deviation Reports, and CAPA Reports to maintain compliance and operational support.
  • Utilize analytical tools like Cause & Effect diagrams, PFMEA, and Root Cause Analysis to address and resolve issues.
  • Conduct assessments for Corrective Actions and Non-conformance.
  • Implement project management strategies at the departmental level to effectively manage multiple projects with varying priorities and resource allocations.

Qualifications

  • Bachelor's degree in an engineering discipline or equivalent professional experience.
  • A minimum of 5 years in a managerial role or 8 years in an engineering role with project leadership experience.
  • Familiarity with regulated environments, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Ability to work cross-functionally is essential for this position.