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Quality Manager

Location: Bedford, MA, United States
Job # 11660073
Date Posted: 12-03-2018

Quality Manager

Small, growing firm is searching for a strong Quality Manager who is versatile and can wear multiple hats and drive Quality for a SaaS-based software product and services firm. This is a fantastic opportunity to join a fast-moving team and have a big impact!

Responsibilities

  • Supervise and manage internal audits and facilitate external audits.
  • Maintain certification and compliance efforts for ISO 9001 and ISO 27001 standards.
  • Monitor and maintain process and product compliance with quality standards and regulations with which the company must comply.
  • Initiate and take an essential role in process improvement and automation initiatives.
  • Trigger and effectively participate in projects that aim to:
    • Investigate, contain, resolve and prevent occurrence of quality incidents and issues, and continuously reduce the cost of quality.
    • Monitor the quality of the business units and processes that are in scope for ISO 9001 and ISO 27001 standards
    • Enable the change within the organization to deliver value to stakeholders with excellent quality.
  • Ensure that policies and procedures align with the company vision of quality.
  • Maintain and enhance the quality system in the organization.
  • Help and support internal system initiatives.

Qualifications
  • BS or MS degree in a technical discipline (CS, MIS, etc)
  • Managed internal Quality Management System, including Controlled Documents, Corrective Actions, internal and external Audits, and other ISO 9001 processes.
  • Experience using Quality Management software.
  • Knowledge of Good Documentation Practices (GDP), computer system validation, and 21 CFR Part 11 Guidelines is a plus.
     
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