Quality Systems Analyst (Med Device) - Irvine, CA

Location: Irvine, CA

Schedule: Standard Office Hours

Duration: 12-Month Contract

Pay range: $40.00 - $45.00 per hour




Summary:

This role offers an exciting opportunity to support the transformation and development of a new Quality Management System within a critical care-focused organization. As a Quality Systems Analyst, you will play a key role in shaping processes, driving compliance, and supporting continuous improvement initiatives.

Key Responsibilities:

• Collaborate with cross-functional stakeholders to understand business needs and develop system requirements, workflows, and processes.
• Support the setup and training of new Supplier Management Quality Systems for a newly formed organization.
• Partner across all levels of the business to ensure alignment, identify and resolve challenges proactively, and escalate issues as necessary.
• Post-transition, support the Supplier Quality Engineering (SQE) team to ensure compliance with applicable quality system requirements and contribute to ongoing improvement efforts and implementation initiatives.

Additional Skills:

• Experience in a quality and/or manufacturing environment within the medical device industry is required.
• Strong proficiency in Microsoft Office Suite.
• Project management experience and familiarity with related tools is preferred.
• Excellent written and verbal communication skills, with the ability to influence and manage relationships effectively.
• Strong problem-solving, analytical, and critical thinking capabilities.

Education and Experience:

• Bachelor's degree or equivalent in a related field.
• 2-4 years of experience in a quality and/or manufacturing environment, specifically within the medical device industry.

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