Lead Quality Assurance Engineer

2 weeks ago

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

"Precision Engineering for Tomorrow's Innovations"

Opportunity at American Tool & Mold: Be a Part of the Future of Manufacturing

Are you driven by a commitment to quality, innovation, and the artistry behind the tools that empower America's industries?

At American Tool & Mold, we are not just a manufacturing entity; we are a passionate group dedicated to shaping the future with accuracy and dependability.

Position Summary: Senior Quality Engineer FDA / ISO13485

The Senior Quality Engineer will deliver seasoned quality assurance expertise to the product development division, prepare and submit 510K documentation to the FDA, and lead corrective action requests to resolve defects, ensuring that products align with customer expectations and regulatory standards.

Supervisory Duties:
  • May assist in the recruitment of quality technicians.
  • Mentors and trains quality technicians and inspectors on established policies and procedures.
  • May contribute to performance evaluations.
Key Responsibilities:
  • Initiates and successfully submits FDA 510K documentation for approval.
  • Conducts internal audits in accordance with ISO-13485 and FDA regulations.
  • Ensures compliance of manufacturing processes with federal, state, local, and industry standards.
  • Reviews design plans, process procedures, testing protocols, and quality manuals to comprehend the scope and requirements of issues.
  • Guarantees that products fulfill the organization's and customers' quality and integrity standards.
  • Supports the product development or operations teams by providing analytical insights throughout the inspection process.
  • Identifies root causes of production issues; recommends and/or implements corrective measures.
  • Analyzes data to detect trends in product quality or defects, aiming to mitigate and prevent future occurrences.
Required Skills and Qualifications:
  • Exceptional organizational skills and meticulous attention to detail.
  • Extensive knowledge of or the ability to swiftly grasp production processes.
  • Excellent interpersonal skills, capable of acting as a liaison among developers, project managers, and customer support.
  • Thorough understanding of federal, state, local, and industry standards, guidelines, and regulations.
  • Strong analytical and problem-solving capabilities.
  • Proficient in Microsoft Office Suite or similar software.
  • Self-motivated and proactive individual.
Education and Experience:
  • A minimum of five years of relevant experience in FDA / ISO-13485.
  • A Bachelor's degree in Engineering or a related field is preferred but not mandatory.
  • ASQ SQE and SQA Certification is advantageous.
Physical Requirements:
  • Extended periods of sitting at a desk and utilizing a computer.
  • Must be capable of lifting up to 15 pounds occasionally.
Travel Requirements:
  • Travel may be required up to 15%.

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

At American Tool & Mold, our workforce is the core of our organization. We appreciate hard work, commitment, and the relentless pursuit of excellence. We believe in fostering the talent of our team members and offering opportunities for growth and advancement.

American Tool & Mold is proud to be an Equal Opportunity Employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees.

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