Quality Assurance Specialist

7 days ago


Berlin, United States Tomz Corporation Full time

**Job Summary:**

We are seeking a highly motivated Quality Assurance Specialist to join our team at TOMZ Corporation. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards in our products and processes.

**Company Overview:

TOMZ Corporation is a leader in manufacturing of devices and components for major medical device companies. Founded in 1988, we continue to be a family-owned and operated organization that offers competitive compensation and excellent benefits.

**Job Description:**

The successful candidate will be responsible for:

  • Ensuring adherence to the TOMZ Quality Management System.
  • Authoring and executing Quality Plans for Quality Product Design and Development projects.
  • Initiating and/or consulting in the development and/or update of Risk Management documentation in cooperation with cross-functional engineering teams per project requirements.
  • Establishing severity and risk-based Process Master Validation Plan strategies with appropriate V&V rationales.
  • Supporting operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Driving Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectivity.

**Required Skills and Qualifications:**

To be successful in this role, you must have:

  • A minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
  • A minimum of 4+ years of experience in a regulated manufacturing environment.

**Estimated Salary Range: $70,000 - $90,000 per year

**Benefits:

We offer a comprehensive benefits package, including health/dental/vision insurance, 401k plan, paid time off, and more.

**Equal Opportunity Employer:

TOMZ Corporation is an Equal Opportunity Employer committed to diversity and inclusion in the workplace.



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