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