Senior Quality Assurance Specialist

6 days ago


Clearwater FL USA, United States AMERICAN TOOL & MOLD Full time
Senior Quality Engineer

At American Tool & Mold, we're seeking a highly skilled Senior Quality Engineer to join our team. As a key member of our product development team, you will be responsible for ensuring the quality and integrity of our medical devices.

Key Responsibilities:
  • Develop and implement quality assurance processes and procedures to ensure compliance with FDA and ISO 13485 regulations.
  • Lead internal audits to ensure adherence to quality standards and identify areas for improvement.
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective actions.
  • Develop and maintain quality documentation, including procedures, work instructions, and training materials.
  • Provide training and guidance to quality technicians and inspectors on quality policies and procedures.
Requirements:
  • Minimum 5 years of experience in quality assurance, with a focus on FDA and ISO 13485 regulations.
  • Strong knowledge of quality systems, including ISO 13485 and FDA regulations.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Strong analytical and problem-solving skills, with the ability to identify and resolve quality-related issues.
  • Proficient in Microsoft Office Suite and other quality management software.
What We Offer:
  • A competitive salary and benefits package, including health, dental, and vision insurance.
  • A 401(k) plan with company match.
  • A robust professional development program, with opportunities for growth and advancement.
  • A dynamic and supportive work environment, with a focus on teamwork and collaboration.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application today.



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