Quality Engineer

Intellectt Inc • Contract • California, United States, US • 1w ago

Role: Quality Engineer III

Location: Irvine, CA

Duration: 12 Months

Job Description:

Lead compliance projects related to EU MDR Class II & III products.
Collaborate with cross-functional teams to assess supplier validation and ensure documentation aligns with EU MDR standards.
Identify gaps in supplier compliance, specifically with Process Validation, and implement remediation activities.
Support quality improvement efforts, such as process and product characterization, for continuous or cost-effective enhancements.
Benchmark and develop effective methods to improve quality processes.
Approve IQ, OQ, PQ, TMV, and Software Validations.
Implement process monitoring and control methods in line with product and process risk levels.
Collect, analyze, and interpret data for process improvements and ongoing support.
Investigate, document, and approve nonconformances, CAPAs, and customer complaints, escalating quality issues when needed.
Ensure accountability for material identification, segregation, and defect classification during manufacturing processes.
Analyze and review the effectiveness of preventive and corrective actions, including root cause investigations.

QUALIFICATIONS

Education & Experience:
Bachelor's degree with 8+ years of experience, Master’s degree with 5+ years, or Doctoral degree with 3+ years of experience.
Relevant experience in manufacturing/operations is essential.
In-depth knowledge of product and process risk management in accordance with FDA and ISO standards is required.
Proven experience in implementing risk mitigation strategies.
Strong technical understanding of manufacturing equipment and processes.

Related Jobs

Engineering - Test Engineering - Test Engineer

LightBox • Full-time • California, United States, US • 5d ago

Quality Assurance (QA) Development Cloud Azure SQL Database Development Database Jobs

5d ago

Test Engineer

Procyon Technostructure • Full-time • California, United States, US • $70k - $75k / year • 5d ago

Quality Assurance (QA) Development Cloud Google

5d ago

Test Engineer

Jobs via Dice • Full-time • California, United States, US • $80.00k - $120k / year • 1w ago

Quality Assurance (QA) Development

1w ago

Quality Engineer

TEKGENCE INC • Contract • California, United States, US • 1w ago

Quality Assurance (QA) Development

1w ago

Senior Quality Assurance Engineer

NTT DATA, Inc. • Full-time • California, United States, US • $128.80k - $191k / year • 2w ago

Quality Assurance (QA) Development

2w ago

Quality Engineer

Barrington James • Contract • California, United States, US • 2w ago

Quality Assurance (QA) Development

2w ago

Quality Engineer

GradBay • Full-time • California, United States, US • 3w ago

Quality Assurance (QA) Development

3w ago

Quality Assurance Engineer

Intellectt Inc • Contract • California, United States, US • 2m ago

Quality Assurance (QA) Development

2m ago

QA Automation Engineer

VARITE INC • Contract • Remote (California, United States, US) • 4m ago

Quality Assurance (QA) Remote Development Quality Assurance

4m ago

Senior Quality Assurance Specialist

Platform Recruitment • Full-time • California, United States, US • 1w ago

Quality Assurance (QA)

1w ago