SKILLS & QUALIFICATIONS:

• Experience in FDA-regulated environments and medical device development.
• Solid understanding of ISO 14971, IEC 62304, and design verification practices.
• Familiarity with computer system validation protocols.
• Strong analytical skills including applied statistical methods.
• Skilled in using tools like JAMA, Jira, Confluence, Slack.
• Excellent documentation, problem-solving, and communication skills.

Ideal Candidate Profile:

• 4+ years of quality engineering or design verification experience.
• Demonstrated ability to work cross-functionally in fast-paced environments.
• Strong understanding of risk management and quality system regulations.

Job Type: Contract
Pay: $40.00 per hour
Expected hours: 40 per week

Experience:

• Design Quality Engineer: 4 years (Required)

Ability to Commute:

• California City, CA 93505 (Required)

Ability to Relocate:

• California City, CA 93505: Relocate before starting work (Required)

Willingness to travel:

• 100% (Required)

Work Location: In perso

ABOUT THE ROLE:

We’re looking for a Design Quality Engineer to support design verification, quality systems, and risk management activities for medical device development. This is a high-impact onsite role requiring strong collaboration across engineering, quality, and regulatory teams.

KEY RESPONSIBILITIES:

• Review and support design verification protocols and test reports.
• Ensure compliance with FDA design control, risk management, and equipment control procedures.
• Guide CAPA, non-conformance, and issue management processes.
• Support release of internal software tool validations.
• Assist in internal audits and phase gate readiness.
• Participate in continuous process improvement initiatives.
• Maintain compliance with Good Documentation Practices (GDP).