Quality and Compliance Auditor

Intervala, LLC • Mount Pleasant Township, PA

4d

About The Position

Responsible for conducting systematic audits of the Quality Management System (QMS) to ensure compliance with ISO 13485:2016 (Medical Devices) and AS9100D (Aerospace) standards. Supports a high-precision contract manufacturing environment specializing in Printed Circuit Board Assemblies (PCBA), full-box builds, and complex cable and harness assemblies. Primary guardian of compliance for high-reliability Electronic Manufacturing Services (EMS).

Requirements

• Ability to remain impartial while auditing peers and departments.
• Exceptional observation skills to catch minute process deviations.
• Strong analytical and problem-solving abilities to assess processes and identify areas for improvement
• Ability to interpret complex assembly drawings, schematics, and customer specific Statements of Work (SOW)
• Working knowledge of ISO 13485:2016, AS9100D, J-STD-001, and IPC-A-610/620
• Bachelor’s degree in a related field (e.g., quality management, quality or process/lean engineering, operations management, etc) and 3 – 5 years in quality auditing within an electronics contract manufacturing environment; or Associate’s degree in a related field and 5 – 7 years experience
• Formal AS9100D or ISO 13485 Internal Auditor training required

Nice To Haves

• Current or former IPC/J-STD certification is highly preferred

Responsibilities

• Plan and execute internal audits across manufacturing processes, including PCBA SMT lines, manual soldering, box build integration, and cable harness fabrication, to verify that the Quality Management System (QMS) remains effective and compliant to the current revisions of ISO 9001, AS9100 and ISO 13485
• Perform floor-level audits to ensure soldering processes, materials, and environment (ESD/MSD) align with J-STD-001 (Class 2 & 3)
• Audit finished goods against IPC-A-610 and IPC/WHMA-A-620 standards to ensure zero-defect delivery to customers
• Audit Device History Records (DHR) and manufacturing travelers for completeness, ensuring full traceability of components and critical aerospace lot codes
• Document audit findings and collaborate with Quality Engineers to drive Root Cause Analysis (RCA) and verify the implementation of CAPA effectivenes to ensure identified gaps are closed and improvements are sustained
• Meticulously document audit findings and prepare detailed reports for management, highlighting non-conformities and areas for improvement
• Participate in Management Review meetings by providing data-driven reports on audit trends and QMS health
• Follow established internal processes and adhere to General Requirements for Team Members

Benefits

• medical
• dental
• vision
• 401(k)
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree