Quality Engineer

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Regular Full-Time Management Vista, CA, US

Salary Range: $70,000.00 To $ Annually

JOB DESCRIPTION

Department:
Quality Assurance

Job Title:

Quality Engineer

Reports To:

Quality Leadership

Location:

Vista, CA (onsite position)
Status:
Full-Time

SUMMARY

VQ Ortho Care provides noninvasive medical products focused on orthopedic bracing and electrotherapy. The Quality Engineer is responsible for applying quality engineering principles and analytical methods to support product and process quality through investigation, analysis, auditing, controlled change and cross-functional quality activities.

The position evaluates product and process issues, supports corrective action and continual improvement and develops subject-matter expertise in assigned areas of the Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The Quality Engineer independently performs assigned Quality activities and works collaboratively with Quality, Manufacturing, Product Development and other functional areas to support effective Quality System and product quality outcomes.

• Apply Quality System principles and requirements in accordance with Company procedures, ISO 13485 and applicable FDA medical device requirements.
• Serve as an internal QMS auditor, independently planning and performing assigned audits of Quality System processes and applicable business functions against ISO 13485, Company procedures and other applicable requirements; evaluate objective evidence, document findings and support appropriate follow-up.
• Develop and maintain extensive knowledge of Company products, components, specifications, manufacturing processes, inspection requirements and known failure modes to support effective Quality evaluation and decision-making.
• Investigate product defects and failures, including evaluation of returned product and relevant product, manufacturing, complaint and Quality history, to characterize failure modes, determine contributing factors and identify recurring or potentially systemic conditions.
• Collect, analyze and interpret product and Quality data to identify trends, variation, recurring conditions and potential quality signals and contribute to the development of meaningful data collection, analysis and reporting methods.
• Lead assigned corrective action, nonconformance, root-cause investigation and Quality improvement activities or participate as an active member of cross-functional teams responsible for evaluating and resolving Quality issues.
• Prepare and update controlled documents as assigned, including initiating change documentation, developing required revisions, obtaining appropriate technical and functional input, verifying proposed changes, evaluating impacts and related downstream activities and completing applicable requirements through the Company's self-service documentation process.
• Support maintenance of Device Master Record (DMR), technical file and other applicable product documentation by completing assigned updates, verifying current and applicable documentation and supporting alignment of affected records and repositories following approved changes.
• Work cross-functionally with Manufacturing, Inspection, Product Development and other applicable functions to address product and process quality issues and support implementation of appropriate corrective and improvement actions.
• Support development and revision of inspection plans, acceptance criteria, sampling methods and other product quality controls associated with product, process, specification and controlled-document changes.
• Provide backup support for Quality Inspection and…