Quality Engineer Medical Devices
Job Location:
Job Location:
Raynham, MA - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
30+ days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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
