Quality Engineer-PCBA Manufacturing (ISO 9001 & ISO 13485)

Company: BIOBRIDGES LLC
Location: Kalamazoo
Posted on: May 18, 2025

Job Description:

Position Summary:

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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.

Keywords: BIOBRIDGES LLC, Portage , Quality Engineer-PCBA Manufacturing (ISO 9001 & ISO 13485), Engineering , Kalamazoo, Michigan