Quality Engineering Manager

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.