Quality Engineer II

Arclin; Alpharetta (GA); On-site; USD 70,000 - 90,000; Full time

Job summary

A manufacturing company located in Alpharetta, GA is seeking a Quality Engineer II to maintain the Quality Management System (QMS) and ensure compliance with regulatory standards. The successful candidate will have a Bachelor’s degree in Engineering, Chemistry, or Business Analytics, with 3-5 years of experience in a manufacturing environment. Key responsibilities include establishing quality standards, facilitating audits, and providing training on compliance requirements. Travel of up to 50% may be required. This position offers a significant opportunity for professional growth within the organization.

Qualifications

• 3-5 years in a manufacturing environment.
• Strong knowledge of ISO, IATF, FDA, GMP regulations.
• Experience with quality management systems.
• LSS Green Belt or higher preferred.
• Willing to travel up to 50%.

Responsibilities

• Establish quality standards by analyzing customer requirements.
• Facilitate quality audits and maintain the quality management system.
• Prepare product and process quality reports by analyzing data.
• Provide training on compliance requirements.

Skills

Knowledge of regulatory standards (ISO 9001, IATF, FDA, GMP)

Statistical Process Control

Quality Management System operation

Education

Bachelor of Science in Engineering, Chemistry, or Business Analytics

Tools

Salesforce

NWA

Job description

Arclin, Inc. is currently looking for a Quality Engineer II for our Corporate Quality team based in Alpharetta, GA. Reporting to the Deputy Quality Director, this role is responsible for maintaining the Quality Management System (QMS) to drive product quality, standards, compliance and customer satisfaction. The Quality Engineer will integrate regulations, corporate Standards, Processes and Guidelines within the company’s QMS to facilitate consistent deployment of company operational, analytical, performance and improvement goals. The individual will also perform periodic audits of the QMS to ensure compliance with relevant regulations and standards, as well as maintain product and company quality certifications. Focus for this role will be maintaining certifications and standards, as well as developing and maintaining the corporate systems in the QMS.

Quality Engineer II Job Responsibilities

• Establishes quality standards by analyzing customer requirements
• Maintains quality product specifications developed by R&T and Sales teams
• Ensures all customer product quality incidents have root causes identified and controlled
• Establishes product inspection standards by studying process control
• Maintains the Arclin Quality Management System
• Facilitates process mapping and FMEA sessions with operations team
• Schedule, identify need for, and perform quality audits
• Establishes standards for the disposition of finished product by following tests methods and procedures
• Establishes rework standards by analyzing inspection results and physical testing methods and procedures
• Prepares product and process quality reports by collecting, analyzing, and summarizing data.
• Serves as the subject matter expert for quality investigation and corrective action tools as well as quality test result data analysis software. (Salesforce and NWA respectfully)
• Develop, implement, and maintain quality compliance programs aligned with regulatory and industry standards (e.g., ISO, FDA, GMP).
• Provide training and guidance on compliance requirements to internal teams.

Quality Engineer II Job Requirements

• Bachelors of Science in Engineering, Chemistry, or Business Analytics
• 3-5 years within a Manufacturing Environment
• Strong knowledge of regulatory standards (ISO 9001, IATF, FDA, GMP, etc.).
• Experience operating and manipulating a QMS (Quality Management System)
• Experience with Statistical Process control
• Prefer LSS Green Belt or higher
• Willing to travel up to 50%
• Experience in implementing a quality management system is a plus
• Experience with writing and reviewing professional documents, i.e. procedures, contracts, and audit reports