Quality Assurance Lead

2 weeks ago

Columbus, Ohio, United States Tosoh BioScience, Inc Full time
Job Overview

Quality Assurance Lead

This role is a full-time position focused on quality assurance processes.

Key Responsibilities

  • Exhibit a comprehensive understanding of regulatory standards and organizational requirements, conducting assessments to identify gaps.
  • Oversee and facilitate internal and supplier audits, non-conformance/corrective action processes, and quality agreements.
  • Act as a Subject Matter Expert and coordinator for Third Party Audits, including FDA and MDSAP.
  • Analyze, establish, and report on quality metrics for the organization and its Quality Management System (QMS) on a monthly and quarterly basis.
  • Conduct independent investigations and analyses, including gap assessments and root cause evaluations, to assess risk levels using appropriate tools.
  • Utilize technical and professional judgment to evaluate the effectiveness of corrective actions and communicate findings to management.
  • Ensure accuracy and completeness of records related to corrective actions, non-conformances, and supplier interactions, referencing relevant quality documents and processes.
  • Perform critical reviews of documentation and change requests, applying analytical skills to assess evidence related to claims or hypotheses.
  • Maintain high service levels in compliance with established rules and standards.
  • Ensure the necessary scientific and technical expertise is applied to all tasks.
  • Contribute to the company's business development and branding efforts.
  • Perform additional duties as required to meet the evolving needs of the organization.

Qualifications and Skills

  • Bachelor's degree in a relevant field such as industrial technology, biology, chemistry, or engineering.
  • A minimum of 8 years of experience in medical device manufacturing, quality assurance, or related fields.
  • Experience managing direct reports is essential.
  • Proficiency in office software applications is required.
  • Experience with SmartSolve or similar Quality Management Systems is necessary.
  • Familiarity with quality concepts including cost of quality, metrics, validation, and problem-solving methodologies.
  • Experience managing audits, document control, training, and quality agreements.
  • Knowledge of HIPAA compliance is preferred.
  • Experience in developing employee training and development plans is a plus.
Company Overview

Tosoh America, Inc. has been a leader in the advanced technology sector since its establishment in 1989. As the parent company of a growing number of subsidiaries, Tosoh America is dedicated to expanding its business lines and operational capabilities throughout North America. Headquartered in Grove City, Ohio, Tosoh America plays a pivotal role in the manufacturing and sale of a diverse range of products, including semiconductor materials, medical diagnostic instruments, and high-performance chromatography media.

The Tosoh Group America companies are involved in various advanced technology fields, providing manufacturing, distribution, regulatory support, and equipment servicing to clients in the IT, chemical, pharmaceutical, and medical industries.

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