QMS Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 88,000 - 137,000; Part time

Job summary

A leading clinical research organization in Indianapolis is seeking a QMS Engineer to provide biocompatibility support, author necessary assessments, and consult on regulatory requirements for medical devices. The ideal candidate will assist in ensuring data accuracy and compliance with quality management system requirements. This is a contract position with a salary range of $88,334.00 to $136,477.00.

Qualifications

• Provide support for biocompatibility processes and ensure information accuracy.
• Author biocompatibility and chemical characterization test plans.
• Provide consultation on regulatory requirements for medical device submissions.

Responsibilities

• Ensure biocompatibility and toxicology data support business objectives.
• Assessment of test data and technical reports.
• Act as a resource for toxicology information related to medical devices.

Job description

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• Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements.
• Responsible for authoring biocompatibility and chemical characterization test plans, author Biocompatibility Assessments and Reports, and assess test data and reports as necessary to support business objectives.
• Responsible for authoring toxicological risk assessment assigned to support divisional objectives.
• Provides consultation on regulatory requirements related to medical device submissions for assigned divisions and in support of corporate initiatives.
• Serve as a resource for biocompatibility and toxicology information for medical devices and materials, which may include issues related to materials of animal origin, colour additives, exposure assessments of chemicals, and other chemical toxicities.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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