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Instrumentation Quality Engineer

Karwell Technologies

Lake Forest, CA

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Biology, Certified Quality Engineer (CQE), Change Control, Communication Skills, Corrective Action, Cross-Functional, Decision Support, Design Verification, Documentation, Electromechanics, Engineering, GxP, Healthcare Quality, ISO (International Organization for Standardization), Instrumentation, Instrumentation Engineering, International Electro-Technical Commission (IEC), Maintain Compliance, Medical Equipment, Problem Solving Skills, Product Development, Product Lifecycle, Product Safety, Product Support, Product Testing, Project Design, Quality Engineering, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Research & Development (R&D), Risk, Risk Management, Root Cause Analysis, Safety Standards, Six Sigma Green Belt, Standard Operating Procedures (SOP), Technical Analysis, Validation Documentation, Validation Plan, Validation Testing
LOCATION
Lake Forest, CA
POSTED
12 days ago
Job Description:
In this role, you will work closely with R&D, Regulatory, Operations, and other cross-functional stakeholders to provide hands-on quality engineering support across the product development lifecycle. You will contribute to key activities such as design controls, risk management, verification and validation, supplier-related quality support, change control, and product transfer. The ideal candidate brings strong technical judgment, demonstrated quality capability, and the ability to operate independently in a fast-paced environment.


Roles & Responsibilities:

  • Provide hands-on quality engineering support for new product development projects and design changes to existing instrumentation products
  • Ensure quality requirements are appropriately applied throughout development, documentation, verification, validation, and transfer activities
  • Partner with project teams to provide practical quality guidance, technical assessment, and risk-based decision support that helps keep development activities moving forward
  • Review and approve design control deliverables, including risk management files, verification and validation documentation, and related development records
  • Evaluate product and process changes for quality and regulatory impact, and support change control activities from assessment through implementation
  • Partner with cross-functional teams to investigate deviations, support root cause analysis, and drive corrective and preventive actions as needed
  • Maintain compliance with applicable GxP requirements, standard operating procedures, and documentation practices

Education & Experience:

  • Bachelor's degree in engineering, life sciences, or a related technical field
  • 2+ years of quality engineering experience in the medical device industry, including direct support of instrumentation or electromechanical product development in an ISO 13485 environment
  • Experience with design controls, change control, and product impact assessments
  • Working knowledge of applicable medical device quality system and regulatory requirements, including ISO 13485, design controls and GxP principles
  • Ability to work effectively across global, cross-functional teams, communicate clearly with technical and non-technical stakeholders, and contribute with minimal ramp-up
  • Experience with risk management in accordance with ISO 14971
  • Experience reviewing or supporting verification and validation protocols, reports, and related documentation
  • Statistical knowledge to support sample size determination and the design of verification and validation studies
  • Working knowledge of applicable product and safety standards, such as the IEC 60601 series and ISO 14971
  • ASQ Certified Quality Engineer (CQE) certification
  • Six Sigma Green Belt or higher.
  • Strong communication, organization, collaboration, and independent problem-solving skills.

About the Company

K

Karwell Technologies

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