Quality Assurance Engineer III

Jobtailor; Concord (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor is seeking a Quality Assurance professional to ensure regulatory compliance and maintain QA systems for Class III medical device products in California. You will support product development, audits, and risk management while guiding verification and validation for software heavy components.

The role requires 5 years of QA experience in manufacturing, familiarity with IEC 62304, and exposure to cybersecurity documentation. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree or equivalent in an engineering or scientific discipline.
• 5 years of quality assurance and quality systems experience supporting manufacturing.
• Experience with Class III medical devices with hardware/software and consumables is a plus.
• Familiarity with software testing methodologies and defect management.
• Ability to support cybersecurity documentation and software lifecycle requirements.
• Experience creating and executing test cases with traceability to requirements.
• Quality certifications such as Six Sigma, CQA, or CRE are desirable.
• Knowledge of IEC 62304 software lifecycle requirements and risk management.

Responsibilities

• Assure compliance with regulations and standards for Class III medical device products.
• Develop, implement, and maintain quality assurance systems for manufacturing processes.
• Lead cross-functional teams on new and sustaining product development and cost-savings projects.
• Guide verification and validation plans, IEC 62304 documentation, and software testing.
• Analyze production data to identify trends and reduce defects.
• Perform product release and quality reviews.
• Maintain quality dashboards and CAPA tracking tools.
• Create and review SOPs, specifications, and QA documentation.
• Conduct internal and supplier audits and support CAPA investigations.
• Interact with departments and suppliers on quality matters.

Skills

Quality Assurance

Software Testing

Risk Management

Data Analysis

Document Control

Auditing

FMEA/HA

DOE

Compliance

IEC 62304

Veeva

SmartSheet

Education

Bachelor’s degree in engineering or science

Tools

SmartSheet

Veeva

CAPA Tracking

Quality Tracking Tools

Dashboards

Job description

• Assure compliance with regulations and standards for Class III medical device combination products and blood components
• Develop, implement, and maintain quality assurance systems and activities for manufacturing and production processes
• Participate in cross-functional teams supporting new and sustaining product development, quality improvement, quality plans, risk management, and cost savings projects
• Guide verification and validation plans, SDLC software testing, IEC 62304 documentation and compliance, cybersecurity documentation, change control, test and sampling methods, sample size determination, and acceptance criteria
• Analyze production, process, and quality data to identify trends and recommend improvements that reduce manufacturing defects
• Perform product release and product quality reviews
• Maintain quality tracking tools and dashboards, including Smartsheet-based RMA, CAPA, supplier action, and field issue tracking
• Develop and implement inspection, testing, and evaluation methods for raw materials, components, and finished products
• Support risk management review meetings and ensure quality documentation meets risk management requirements
• Create and review regulated documents, including SOPs, specifications, verification and validation protocols and reports, quality control plans, and reliability plans
• Conduct internal and supplier audits
• Support CAPA investigations and effectiveness reviews
• Interact regularly with departments and suppliers regarding quality
• Support software lifecycle activities, including requirements traceability, software risk management documentation, IEC 62304 compliance reviews, and Design History File documentation
• Perform other related duties as required

Requirements

• Bachelor’s degree or equivalent in an engineering or scientific discipline, including electrical, mechanical, biomedical, software, systems, or process engineering
• 5 years of quality assurance and quality systems experience supporting manufacturing
• Experience with Class III medical devices with hardware/software and consumables is a plus
• Familiarity with software testing methodologies and defect management
• Ability to support cybersecurity documentation and software lifecycle requirements
• Experience creating and executing test cases, including traceability to requirements
• Quality certification such as Six Sigma, CQA, or CRE is desired
• Experience developing and monitoring Key Process Indicators (KPIs) is desirable
• Working knowledge of IEC 62304 software lifecycle requirements, software risk management, requirements traceability, and design control documentation in a regulated environment is preferred
• Experience defining and monitoring supplier quality agreements is desirable
• Thorough knowledge of current medical device manufacturing regulatory requirements and international standards; blood components expertise is a plus
• Ability to work effectively cross-functionally
• Strong verbal, written, interpersonal, and listening communication skills
• Attention to detail and accuracy; strong audit observation skills
• Ability to use FMEA/HA, DOE, Six Sigma, SmartSheet, and Veeva
• Flexibility and ability to adapt to change
• Ability to set priorities and effectively manage time across multiple activities and responsibilities
• Willingness to travel domestically and internationally, approximately 10% as needed

Core Competencies

Demonstrates expertise in quality assurance systems for Class III medical devices, including compliance with IEC 62304 and regulatory requirements. Proficient in developing quality plans, conducting audits, and implementing risk management strategies to enhance manufacturing processes.

Highest-signal resume keywords

• Quality Assurance Systems
• IEC 62304 Compliance
• Cybersecurity Documentation
• Six Sigma Certification
• Supplier Quality Agreements

ATS Optimization Keywords

Hard Skills

• Quality Assurance
• Software Testing Methodologies
• Test Case Development
• Risk Management
• Data Analysis
• Regulatory Compliance
• Verification and Validation
• Manufacturing Processes
• Quality Control Plans
• FMEA/HA

Soft Skills

• Strong Communication Skills
• Attention to Detail
• Interpersonal Skills
• Time Management
• Flexibility

Certifications & Qualifications

• Six Sigma
• CQA
• CRE

Industry Keywords

• Class III Medical Devices
• Blood Components
• Manufacturing Regulatory Requirements
• Quality Improvement
• Cross-Functional Collaboration

Tools & Technologies

• SmartSheet
• Veeva
• CAPA Tracking
• Quality Tracking Tools
• Dashboards