Job Description

Position Summary:

We are seeking a proactive and detail-oriented Quality Engineer to support and enhance our Printed Circuit Board Assembly (PCBA) manufacturing operations in accordance with ISO 9001 and ISO 13485 standards. This position plays a critical role in ensuring product quality, regulatory compliance, and continuous improvement across production processes. The ideal candidate will have a strong background in electronics manufacturing and a thorough understanding of quality systems and medical device regulatory requirements.

Primary responsibilities include:

• Implement and maintain quality assurance processes to ensure compliance with ISO 9001 and ISO 13485 standards throughout the PCBA production lifecycle.
• Develop, review, and improve quality documentation including control plans, inspection instructions, and validation protocols.
• Collaborate with Engineering, Production, and Supply Chain to address quality issues and ensure consistent process capability and product conformance.
• Lead root cause analysis and Corrective and Preventive Actions (CAPA) for internal and external nonconformances.
• Conduct internal audits and support external audits by customers, notified bodies, and regulatory agencies.
• Support product and process validations, including IQ/OQ/PQ activities and documentation.
• Manage supplier quality performance, including audits, incoming inspection, and issue resolution.
• Perform data analysis using SPC and other statistical tools to monitor trends and drive continuous improvement initiatives.
• Assist in training personnel on quality procedures, inspection methods, and regulatory requirements.
• Ensure compliance with applicable regulatory requirements including FDA 21 CFR Part 820 and relevant sections of EU MDR, as applicable.
• Track and report compliance metrics, audit findings, and quality improvement initiatives.
• Perform other duties as assigned.

Requirements:

• Bachelor’s degree in engineering (Electrical, Mechanical, or related field), Quality Assurance, or a relevant technical discipline. Or an equivalent amount of work experience is also acceptable.
• 2+ years of experience in a quality engineering role in PCBA manufacturing or electronics-based medical devices, a plus.
• In-depth knowledge of ISO 9001 and ISO 13485 standards, a plus.
• Experience with quality tools such as FMEA, 8D, Root Cause Analysis, and SPC.
• Strong understanding of manufacturing and inspection processes related to surface mount technology (SMT), through-hole assembly, and testing, a plus.
• Certified Quality Engineer (CQE) or equivalent certification, a plus.
• Experience with FDA QSR (21 CFR Part 820), a plus.
• Familiarity with IPC standards (IPC-A-610, IPC-J-STD-001, etc.), a plus.
• Proficient in quality data analysis and reporting tools (e.g., Minitab, Excel, or similar), a plus.

Soft Skills:

• Enthusiasm for working at a small company with fit-for-purpose infrastructure and limited resources.
• Able to embed at the client and demonstrate presence.
• Highly proactive and communicative.
• Able to diplomatically oversee communications with team members.
• Excellent oral and written communication skills, team player, ability to work flexibly in a collaborative environment and assist team members.
• Able to work independently on competing priorities in a fast-paced and dynamic environment.

Expected Commitment:

This engagement will be for 6 months to start with the possibility of consulting to perm thereafter. This role is full-time. The client would like the professional on site.

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