Quality Assurance Coordinator

The West Group Ltd; Garland (TX); On-site; USD 60,000 - 95,000; Full time

Benefits offered by this job

401(k) with company match

Paid holidays and vacation

Team performance bonus

Job summary

The West Group USA in Garland, TX seeks a Quality Assurance Coordinator to lead incoming inspection, maintain process validation, and act as the site quality systems keeper. You will coordinate with production, shipping, and corporate quality to ensure product conformity and regulatory compliance.

This non-management role requires meticulous attention to detail, strong communication, and the ability to work independently while interfacing with multiple teams across the site and corporate

Qualifications

• 3+ years of quality assurance or quality systems experience in a regulated manufacturing environment (medical device strongly preferred).
• Hands-on experience with incoming inspection using precision tools (calipers, pin gauges, etc.).
• Working knowledge of process validation, cleanroom standards, and quality documentation.
• Strong organizational and communication skills for corporate liaison and complaint handling.
• Proficient with quality systems, ERP, and Microsoft Office.
• High attention to detail and ability to work independently as an individual contributor.
• Bachelor’s degree in a scientific or technical field preferred; ASQ certification a plus.
• Must pass background check, drug screen, and be eligible to work in the U.S.

Responsibilities

• Approve incoming, in-process, or finished goods by confirming to specification / inspection requirements; conduct tests and reject nonconforming items.
• Document inspection results by completing reports and logs.
• Handle customer/supplier returns; liaise with production manager; close out reports and logs.
• Maintain traceable records and document control.
• Review supplier First Article Inspection reports.
• Investigate quality issues; identify root cause; implement corrective actions (8D).
• Serve as site process keeper for quality procedures and documentation.
• Act as liaison between Garland site and corporate quality.
• Participate in cross-functional investigations of non-conformities (8D/5Y/Ishikawa).
• Maintain and support process validation activities; ensure documentation current.
• Assist in developing and implementing quality standards and control systems.
• Collaborate with other departments on QMS improvements and document support.
• Support internal and external audits, CAPA processes, and CI initiatives.
• Promote CI within the business and team.
• Learn and adhere to operational procedures and systems.
• Lead ISO 13485 and customer quality audits.
• Oversee cleanroom compliance and environmental monitoring programs.
• Provide additional support as required.

Skills

Quality assurance

Quality systems

Medical devices

Incoming inspection

Precision measurement

Process validation

Cleanroom standards

Quality documentation

ERP

Microsoft Office

Attention to detail

Independent contributor

Education

Bachelor's degree in science/engineering/technical field

ASQ certification (preferred)

Tools

ERP systems

Microsoft Office

Job description

The West Group USA is a growing medical manufacturing company in Garland, TX, seeking a Quality Assurance Coordinator. This position is the key site-level quality individual contributor responsible for leading incoming inspection activities, maintaining process validation and cleanroom compliance, serving as the process keeper for site quality systems, acting as the primary liaison between our Garland site and corporate quality, and managing site customer complaints (with support from corporate quality).

This is not a people-management role. Success depends on strong technical attention to detail, process ownership, clear communication, and the ability to work independently while coordinating closely with production, shipping/receiving, and corporate quality teams.

Duties

• Approve incoming, in-process, or finished goods / materials by confirming to specification / inspection requirements inclusive of documentation; conducting visual and measurement tests; rejecting and returning unacceptable products / materials.
• Document inspection results by completing reports and logs.
• Document and process customer / supplier returns liaising with production manager and company buyer; completing reports and logs; follow through to closure.
• Maintain traceable records.
• Review supplier First Article Inspection reports
• Investigate quality related issues occurring both internally and by the Customer, by identifying the root cause and implementing acceptable corrective actions (8Ds).
• Serve as the site process keeper for quality procedures, work instructions, and related documentation.
• Act as the primary liaison between the Garland site and corporate quality team on quality matters.
• Participate in cross-functional investigation of non-conformities using recognised problem-solving methodology such as 8D/5Y/Ishikawa.
• Maintain and support process validation activities, ensuring documentation and compliance are current.
• Assist in developing and implementing quality standards and control systems.
• Liaise with other departments regarding improvements to Internal QMS Procedures and Documents as necessary in addition to the creation and support.
• Support internal and external audits, CAPA processes, and continuous improvement initiatives.
• Actively promote CI within the business and the team.
• Learn and adhere to operational procedures and systems.
• Actively promote Quality throughout the organisation.
• Lead ISO 13485 and customer quality audits
• Oversee cleanroom compliance and environmental monitoring programs.
• Provide additional support to The West Group as required.

Skills

• 3+ years of quality assurance or quality systems experience in a regulated manufacturing environment (medical device strongly preferred).
• Hands-on experience with incoming inspection using precision tools (calipers, pin gauges, etc.).
• Working knowledge of process validation, cleanroom standards, and quality documentation.
• Strong organisational and communication skills for corporate liaison and complaint handling.
• Proficient with quality systems, ERP, and Microsoft Office.
• High attention to detail and ability to work independently as an individual contributor.
• Bachelor’s degree in a scientific or technical field preferred; relevant certifications (e.g., ASQ) a plus.
• Must pass background check, drug screen, and be eligible to work in the U.S.

Medical, dental, vision, and additional insurance options

• 401(k) with company match (100% up to 3% of pay + 50% on next 3%)
• 10 paid holidays + paid vacation (10 days to start, +1 day per year of service up to 20 days)
• Quarterly team performance bonus opportunity (when quality, on-time, and production goals are met)
• And more

We are an equal opportunity employer and encourage all qualified candidates to apply.