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Quality Engineering Manager

2 months ago

Bedford, United States EPM Scientific Full time

Quality Manager

In this leadership role, you'll also manage a team of technicians, ensuring they have the resources and training to succeed.


Responsibilities

  • Lead the implementation of new customer processes, from development to production.
  • Manage projects effectively, utilizing strong organizational skills and resource allocation.
  • Develop and maintain process validation documents, ensuring compliance with regulations.
  • Design and develop testing methodologies for new and existing processes.
  • Analyze workflow, processes, equipment, and tooling to identify areas for improvement.
  • Collect and analyze data to identify trends and track key performance indicators (KPIs).
  • Support production activities, including setup, configuration, and certification.
  • Evaluate production feasibility and provide resource assessments for cost models.
  • Collaborate with customers and regulatory personnel on quality and design matters.
  • Attend meetings to discuss quality issues and implement solutions.
  • Recommend improvements to development and design processes.
  • Oversee departmental compliance with company quality policies, ISO standards, and other regulations.


Qualifications

  • Bachelor's degree in Manufacturing, Industrial, Electrical, or Mechanical Engineering (preferred).
  • 3+ years of experience in a leadership role.
  • 5+ years of hands-on experience in a medical device manufacturing environment (required).
  • Experience working in a regulated environment (required).
  • Collaborative mindset and a team-oriented approach.
  • Familiarity with LEAN principles (a plus).
  • Experience with FMEAs and IQ/OQ/PQs


Desired Skills

  • Strong personnel management skills.
  • Excellent proficiency in spreadsheets (Excel) and MS Word.
  • Working knowledge of ISO standards.