Lead Quality Assurance Engineer

2 weeks ago

Clearwater, Florida, United States AMERICAN TOOL & MOLD Full time
Job Overview

"Precision Engineering for a Stronger Tomorrow"

At American Tool & Mold, we are at the forefront of manufacturing excellence, dedicated to precision and innovation in every tool we create.

Position Summary: Senior Quality Engineer FDA / ISO13485

The Senior Quality Engineer plays a crucial role in ensuring quality assurance throughout the product development lifecycle. This position involves the preparation and submission of 510K documentation to the FDA, leading corrective action responses for defects, and guaranteeing that products align with customer specifications and regulatory standards.

Key Responsibilities:
  • Initiate and manage the FDA 510K documentation process, ensuring successful submissions.
  • Conduct internal audits in compliance with ISO-13485 and FDA regulations.
  • Verify that manufacturing processes adhere to all applicable federal, state, local, and industry standards.
  • Review design plans, process documentation, testing protocols, and quality manuals to fully understand project requirements.
  • Ensure product quality and integrity meet both organizational and customer expectations.
  • Provide analytical support to product development and operations teams during inspection processes.
  • Identify root causes of production issues and recommend corrective actions.
  • Analyze quality data to detect trends and implement strategies to prevent future defects.
Required Skills and Qualifications:
  • Strong organizational skills with a keen attention to detail.
  • In-depth knowledge of production processes or the ability to learn quickly.
  • Excellent interpersonal skills to effectively communicate with developers, project managers, and customer support teams.
  • Comprehensive understanding of relevant federal, state, local, and industry regulations.
  • Robust analytical and problem-solving capabilities.
  • Proficiency in Microsoft Office Suite or similar software.
  • Self-motivated and proactive in approach.
Education and Experience:
  • A minimum of five years of relevant experience in FDA / ISO-13485 environments.
  • A Bachelor's degree in Engineering or a related field is preferred but not mandatory.
  • ASQ SQE and SQA Certification is an advantage.
Physical and Travel Requirements:
  • Ability to sit for extended periods while working on a computer.
  • Occasional lifting of up to 15 pounds may be required.
  • Travel may be necessary, estimated at 15%.

We offer a competitive compensation and benefits package, including health, dental, vision, life, ADD, LTD, STD insurance, a 401(k) plan with company match, and a comprehensive professional development program.

At American Tool & Mold, our employees are the foundation of our success. We value dedication, hard work, and the relentless pursuit of excellence. We are committed to fostering the growth and development of our team members.

American Tool & Mold is proud to be an Equal Opportunity Employer, celebrating diversity and promoting an inclusive environment for all employees.

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