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Quality Engineer Lead

2 months ago

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

The Senior Quality Engineer will provide experienced quality assurance support to the product development team, document and submit 510K to FDA, Lead CAR resolving of defects and ensuring the product meets customer specifications and regulatory requirements.

Key Responsibilities:
  • Initiates FDA 510K documentation and successfully submitted to the FDA for approval.
  • Performs Internal Audits to ISO-13485 and FDA Regulations.
  • Ensures manufacturing processes comply with federal, state, local, and industry standards and regulations.
  • Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of the problem.
  • Ensures that products meet the organization and customers' quality and product integrity requirements.
  • Supports the product development or operations team by providing analysis and expertise throughout the inspection process.
  • Identifies root causes of problems in the production process; recommends and/or implements corrective actions.
  • Analyzes data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects.
Requirements:
  • Excellent organizational skills and attention to detail.
  • Extensive knowledge of or the ability to quickly learn production processes.
  • Excellent interpersonal skills with the ability to serve as a liaison with developers, project managers, and customer support.
  • Thorough understanding of federal, state, local, and industry standards, guidelines, and regulations.
  • Strong analytical and problem-solving skills.
  • Proficient with Microsoft Office Suite or related software.
  • Self-starter and motivated individual
Education and Experience:
  • At least five years of related experience in FDA / ISO-13485
  • Bachelor's degree in Engineering or related discipline not required but strongly recommended.
  • ASQ SQE and SQA Certification - preferred
Physical Requirements:
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift 15 pounds at times.
Travel Requirements:
  • Travel could be 15%.