Senior Design Quality Assurance Engineer

The ideal candidate has strong Design Quality Assurance experience, takes ownership of quality activities, and can work independently while collaborating effectively with cross-functional teams. This role focuses on product risk management, nonconformance investigations, CAPA, design control compliance, and Design History File (DHF) assessment and remediation.

Title : Senior Design Quality Assurance Engineer

Location: Santa Clarita, CA
Work Arrangement: Onsite
Employment Type: Contract W2
Duration: 6 8 Months
Rate: $55 $63/hr W2

About the Role

We are seeking a Senior Design Quality Assurance Engineer to provide hands-on quality support for sustaining medical device products. This role focuses on product risk management, nonconformance investigations, CAPA, design control compliance, and Design History File (DHF) assessment and remediation.

The ideal candidate has strong Design Quality Assurance experience, takes ownership of quality activities, and can work independently while collaborating effectively with cross-functional teams.

Key Responsibilities

• Own and maintain product risk management activities, including risk assessments and supporting documentation.

• Lead and support nonconformance investigations, including NCEP/NCMR documentation, investigation, and resolution.

• Manage CAPA activities, including root cause analysis, corrective actions, and effectiveness checks.

• Conduct DHF assessments and support remediation to address documentation gaps and design control deficiencies.

• Provide ongoing Design Quality Assurance support for sustaining medical device products throughout the product lifecycle.

• Evaluate product and design changes to ensure appropriate risk assessments, documentation, and regulatory compliance.

• Collaborate with engineering, quality, and other cross-functional teams to investigate quality issues and maintain product compliance.

• Develop, review, and maintain quality documentation in accordance with applicable procedures and regulatory requirements.

• Communicate quality risks, project updates, and recommended actions to relevant stakeholders.

Required Qualifications

• 4 10 years of experience in medical device quality engineering or a related regulated industry.

• Strong experience in Design Quality Assurance, preferably supporting sustaining products.

• Demonstrated ownership of product risk management activities and documentation.

• Hands-on experience with nonconformance management, including NCEP/NCMR, and CAPA processes.

• Strong root cause analysis, problem-solving, and technical documentation skills.

• Excellent written and verbal communication skills.

• Ability to work independently and collaborate effectively across cross-functional teams.

Preferred Qualifications

• Experience conducting DHF assessments, remediation, or design control gap assessments.

• Experience supporting sustaining engineering and ongoing product quality activities.

• Familiarity with ISO 13485, ISO 14971, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable design control requirements.

• Experience leading root cause investigations and implementing quality improvements.

• Ability to build effective working relationships within a small, collaborative team.

Salary

The hourly rate for this position is $59 $64/hr on W2, depending on experience and qualifications.

Benefits

Eligible employees may have access to benefits in accordance with the applicable benefit plans and eligibility requirements.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.