Essential Responsibilities:

Support and maintain compliance activities related to the NORTH™ PAPR product line Prepare, organize, maintain, and support NIOSH submission files and certification documentation Support ongoing NIOSH approval maintenance and regulatory compliance activities Maintain and support

FDA, ISO

13485, and NIOSH quality system requirements Manage and support CAPA investigations, root cause analysis, and corrective actions Maintain design control and engineering change control documentation Support validation activities including process, product, and equipment validations Maintain technical drawings, BOMs, specifications, and controlled documentation Support configuration management of approved PAPR kits and component combinations Review and maintain SolidWorks and AutoCAD drawings and related engineering files Support internal and external audits, inspections, and regulatory inquiries Coordinate with manufacturing, purchasing, warehouse, and quality teams regarding product changes and compliance requirements Assist with supplier qualification and component compliance activities Maintain organized records and technical documentation to support regulatory compliance and continuity

Preferred Qualifications:

Bachelor's degree in Engineering, Quality, Regulatory Affairs, or related technical field Experience with respiratory protection products, PAPRs, or industrial safety products preferred Experience preparing or supporting NIOSH submissions strongly preferred Experience with Honeywell, Honeywell North, 3M, MSA, Bullard, Draeger, or similar respiratory product lines preferred Working knowledge of FDA quality systems, ISO 13485, and NIOSH requirements Experience with CAPA systems, validations, design controls, and change management AutoCAD experience required Strong organizational and documentation skills Ability to manage multiple projects and priorities in a fast-paced environment Strong communication and cross-functional collaboration skills

Preferred Experience:

PAPR or respirator product experience Regulated manufacturing environment Technical documentation and engineering change control Product compliance and certification maintenance Quality systems and audit support

Location:

North Richland Hills, TX Company Overview:

Prestige Ameritech is a domestic manufacturer of respiratory protection and medical products committed to quality, compliance, and innovation. The North Quality and Compliance Engineer will play a critical role in supporting the continued growth and compliance of the NORTH™ respiratory product line.

Benefits:

Health insurance

Work Location:

In person

Pay:

$80,000.00 - $100,000.00 per year

Benefits:

Health insurance

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