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ECO ​/ Test Method Validation (TMV) Coordinator

Job in Woodbridge Township, Middlesex County, New Jersey, 07095, USA
Listing for: Stark Pharma Solutions Inc
Full Time position
Listed on 2026-08-04
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 70000 - 90000 USD Yearly USD 70000.00 90000.00 YEAR
Job Description & How to Apply Below

Hi,

We are hiring talented professionals for an ECO / Test Method Validation (TMV) Coordinator position.

Position: ECO / Test Method Validation (TMV) Coordinator

Location: Utah

Duration: Long Term

Job Overview

We are seeking an ECO / Test Method Validation (TMV) Coordinator to support Engineering Change Order (ECO) and Test Method Validation (TMV) activities in a regulated medical device manufacturing environment. The role involves coordinating engineering changes, maintaining documentation, and collaborating with cross-functional teams to ensure compliance with quality and regulatory standards.

Key Responsibilities
  • Coordinate Engineering Change Orders (ECOs).
  • Support Test Method Validation (TMV) activities.
  • Maintain engineering and quality documentation.
  • Collaborate with Engineering, Quality, Manufacturing, and Regulatory teams.
  • Support change control and risk management activities.
  • Ensure compliance with quality standards and Good Documentation Practices (GDP).
Required Qualifications
  • Experience with ECO and/or TMV activities.
  • Experience working in a regulated medical device manufacturing environment.
  • Knowledge of ISO 9001, ISO 13485, and ISO 14971 standards.
  • Familiarity with Good Documentation Practices (GDP).
  • Experience supporting FMEA and risk management documentation.
  • Proficiency with Microsoft Office applications.
  • Strong communication, organizational, and cross-functional collaboration skills.
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