Quality Engineer

Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. we are hiring a Quality Engineer a healthcare technology company

Position Summary

The Quality Engineer will be part of the Quality Assurance team, responsible for ensuring compliance with applicable regulatory requirements and standards, maintaining quality system processes, and supporting the development and manufacture of in vitro diagnostic (IVD) products.

Essential Functions & Responsibilities

Quality Systems Management

• Maintain and improve Quality Management System (QMS) processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other regulatory standards.
• Conduct internal audits and support external audits, including regulatory inspections.

Product Development Support

• Collaborate with cross-functional teams to ensure design controls, risk management, and product validations comply with regulatory and quality requirements.
• Participate in the development of quality requirements, acceptance criteria, and test methods for components, assemblies, and devices.
• Ensure proper documentation of design history files (DHF) and participate in design reviews.
• Perform phase gate reviews for development projects and prepare quality-related deliverables per design control processes.

Manufacturing Support

• Work with manufacturing teams to monitor and improve process quality.
• Develop manufacturing process quality requirements and methods as needed.
• Prepare or support equipment qualification and process validation protocols, execution, and reports.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for nonconformances.

Supplier Quality Management

• Qualify suppliers in accordance with company processes and regulatory requirements.
• Evaluate and monitor supplier performance to ensure materials and components meet specifications.
• Conduct supplier audits and manage supplier corrective actions as needed.

Compliance and Documentation

• Prepare and review technical documentation to support regulatory submissions.
• Ensure proper documentation and traceability of quality records, including complaints, deviations, and change controls.
• Perform quality trend analyses to demonstrate system effectiveness and compliance.

Training and Support

• Provide training to team members on quality system processes and regulatory requirements.
• Support continuous improvement initiatives and foster a culture of quality throughout the organization.

Other Tasks

• Complete additional duties as assigned.

Qualifications

Required

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3–5 years of experience in quality engineering within the medical device or IVD industry.
• Strong knowledge of ISO 13485 and FDA QSR.
• Proficiency in quality tools and methodologies such as FMEA, SPC, and Root Cause Analysis.
• Experience with CAPA, nonconformance investigations, and risk management.

Preferred

• Certified Quality Engineer (CQE) or equivalent certification.
• Experience with statistical analysis tools and software.
• Familiarity with software quality assurance for medical devices.

Technical Knowledge

Tools & Equipment

• PC, scanners, facsimile machines, voice mail and email systems, and other common office equipment.

Software

• Proficiency in Google Workspace and other relevant software tools.

Eastridge Workforce Solutions is committed to connecting professionals with meaningful career opportunities. Apply now to join a dynamic and innovative team.

Benefits: Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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