Device Quality Assurance Engineer — Southlake (Onsite)

Southlake Medical Devices; Southlake (TX); Presencial; USD 70.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare coverage

Disability & Life Insurance

401(k) with match

Paid Time Off

Descripción de la vacante

Southlake Medical Devices is seeking a detail-oriented and proactive Device Quality Assurance Specialist to join our growing team in Southlake, TX. In this role, you will be the primary steward of our device quality standards, ensuring that every product reaching our practitioners meets the highest benchmarks for safety, efficacy, and regulatory compliance.

You will report directly to the Head of Quality/Chief Quality Officer, serving as a critical bridge between our operations, supply chain,

Formación

• Bachelor’s degree in a scientific, engineering, quality, or healthcare-related discipline.
• 3+ years of experience in Quality Assurance, Quality Control, or supplier quality within a regulated industry (Medical Device, Pharmaceutical, or Biotech).
• Proficiency in applying product specifications, technical drawings, and inspection criteria.
• Strong understanding of documentation practices, including the ability to maintain GxP-compliant records.
• Experience with FDA regulatory requirements, ISO 13485, or similar Quality Management System standards.
• High level of proficiency with standard business software and the ability to adapt to new electronic quality management systems.

Responsabilidades

• Manage the end-to-end receipt of device shipments, including strict quarantine and release protocols.
• Conduct thorough incoming inspections, verifying product identity, UDI, lot numbers, and packaging integrity.
• Execute dimensional and functional testing using established sampling plans and inspection procedures.
• Maintain precise, auditable records for lot-level traceability and device history.
• Identify, segregate, and document nonconforming product while coordinating effective resolutions with contract manufacturers.
• Support the development and maintenance of device-specific procedures, work instructions, and risk documentation.
• Monitor complaint logs and assist in investigation processes to ensure patient safety and regulatory compliance.
• Collaborate with internal departments to ensure all quality events are tracked and closed in a timely manner.
• Act as a key liaison for supplier performance monitoring and internal audit readiness.

Conocimientos

Quality Assurance

Documentation

FDA Regulations

GxP

Quality Management

Educación

Bachelor’s degree in a scientific, engineering, quality, or healthcare-related discipline

Descripción del empleo

Southlake Medical Devices is seeking a detail-oriented and proactive Device Quality Assurance Specialist to join our growing team in Southlake, TX. In this role, you will be the primary steward of our device quality standards, ensuring that every product reaching our practitioners meets the highest benchmarks for safety, efficacy, and regulatory compliance.

You will report directly to the Head of Quality/Chief Quality Officer, serving as a critical bridge between our operations, supply chain,