Job Description

Role: Quality Engineer

Duration: 12 months

Location: Onsite Raynham MA

We are seeking a Quality Engineer with strong Quality Systems (QMS) experience to support a leading medical device organization. This individual will play a key role in maintaining and improving quality processes, ensuring compliance with regulatory requirements, and partnering with cross-functional teams on critical quality initiatives.

This role will be hands-on in supporting non-conformances, validation activities, and change control processes (including change orders), helping to drive quality and compliance across the organization.

Key Responsibilities

• Support and manage non-conformance (NC) investigations, including root cause analysis and CAPA activities
• Assist with validation activities (IQ/OQ/PQ), ensuring proper documentation and execution
• Drive and support change management processes, including change orders and engineering changes
• Collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams to ensure compliance with internal procedures and industry standards
• Maintain and improve Quality Management System (QMS) processes and documentation
• Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements
• Support internal and external audits, including audit readiness and remediation efforts
• Utilize and manage documentation within Windchill or similar PLM/digital quality systems

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