Quality Assurance Engineer III

Simple Staffing Group

. Assure compliance with regulations and standards for Class III combination medical devices and blood components .

Posted 9/19/2026full-timeConcord • California • United StatesMid-LevelSenior💰 $121,000 - $148,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance systems and compliance for Class III medical devices, with a strong focus on software lifecycle requirements, risk management, and regulatory documentation. Proficient in analyzing quality data and implementing improvements to reduce manufacturing defects while ensuring adherence to industry standards.

Highest-signal resume keywords

Quality Assurance SystemsIEC 62304 ComplianceSoftware Testing MethodologiesRegulatory RequirementsSix Sigma Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceSoftware TestingRisk ManagementTest Case DevelopmentData AnalysisRegulatory DocumentationQuality Control PlansSupplier Quality AgreementsKey Process IndicatorsChange Control

Soft Skills

Communication SkillsAttention to DetailCross-Functional CollaborationTime ManagementAdaptability

Tools & Technologies

SmartSheetVeevaFMEA/HADOECAPA Tracking

Certifications & Qualifications

Six SigmaCQACRE

Industry Keywords

Medical Device ManufacturingClass III DevicesBlood ComponentsQuality ImprovementRegulatory Compliance

Tech Stack

Tools & technologies

Cyber SecuritySDLC

About the role

Key responsibilities & impact

Assure compliance with regulations and standards for Class III combination medical devices 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
Provide guidance on verification and validation plans, SDLC software testing, IEC 62304 lifecycle documentation, 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 and control 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
Participate in developing and implementing 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 and support internal and supplier audits
Support CAPA investigations and effectiveness activities
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

What you’ll need

Bachelor’s degree or equivalent in engineering or scientific discipline; electrical, mechanical, biomedical, software, systems, or process engineering
5 years of quality assurance and quality systems experience supporting manufacturing
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 desired (Six Sigma, CQA, CRE)
Experience with 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 with defining and monitoring supplier quality agreements is desirable
Thorough knowledge of current medical device manufacturing regulatory requirements and international standards; blood components expertise a plus
Ability to work effectively cross-functionally
Strong verbal, written, interpersonal, and listening communication skills
Attention to detail and accuracy; highly observant during audits
Ability to use quality tools such as FMEA/HA, DOE, Six Sigma, SmartSheet, and Veeva
Ability to adapt to changing conditions
Ability to prioritize and manage time across multiple activities and responsibilities
Willingness to travel domestically and internationally approximately 10% as needed

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Domestic partner benefits
Paid maternity and paternity leave
Healthcare and dependent care flexible spending accounts
Life and accidental death insurance
Long-term and short-term disability insurance
Matching 401(k)
RSUs
Employee Assistance Program (EAP)
Legal and financial services
Health club membership discounts
Tuition reimbursement