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Director of Quality

North Billerica, MA 01862

Posted: 04/16/2024 Job Number: 33970

Job Description

Position Summary:
  • Role: Executive position overseeing the Quality Management System (QMS), Quality Department, and Documentation.
  • Reporting: Reports to the Group President, providing leadership for ensuring compliance with quality requirements across different departments and processes.
  • Responsibilities: Focus on QMS development, performance metrics, compliance with standards (ISO9001, ISO13485, cGMP), and meeting customer requirements.

Essential Functions:
  • Strategic Oversight: Evaluate QMS to ensure products and processes meet quality, integrity, functionality, and traceability standards.
  • Collaboration: Work with management and senior staff across departments to establish quality metrics.
  • Quality Standard Implementation: Develop and implement testing and evaluation processes, ensuring regulatory compliance and cross-departmental support.
  • Stakeholder Communication: Facilitate communication with internal and external stakeholders in quality management.
  • Continuous Improvement: Assess yield results and collaborate for overall Quality output enhancement.
  • Documentation and Reporting: Review and own quality control documentation, report quality control status to executive leadership and regulatory agencies when needed.
  • Resource Management: Oversee staffing levels and resources to meet quality objectives.
  • Decision Making: Ability to make critical decisions while adhering to company procedures.

Skills & Abilities:

  • Education: Bachelor's degree in Engineering or Quality Management.
  • Experience: 8-10 years of related experience, preferably 5 years as a quality manager or similar role. Preferred training in Six Sigma, Lean Manufacturing, IPCA610, and IPCA620 standards.
  • Computer Skills: Proficiency in Microsoft Office Suite, database management, and reporting.

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