Manufacturing Quality Technician

Creative Solutions Services, LLC; New Kensington (Westmoreland County); On-site; USD 55,000 - 75,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Manufacturing Quality professional to support production operations, supplier quality, validation, and process improvement within a regulated production environment.

The role emphasizes manufacturing transfers, quality system compliance, CAPA activities, deviation investigations, and continuous improvement initiatives to uphold product quality and regulatory standards.

Qualifications

• 2+ years of experience in Manufacturing Quality, QA, supplier quality, process quality, or validation.
• Hands-on CAPA, NCRs, quality documentation, inspections, and audit support.
• Familiarity with manufacturing quality systems, process validation, and regulated production environments.
• Strong documentation, organizational, and problem-solving skills.

Responsibilities

• Support daily manufacturing quality activities and ensure compliance with established quality standards.
• Assist with process validation, verification activities, and production readiness initiatives.
• Perform inspections, maintain quality documentation, and support process monitoring activities.
• Participate in CAPA, Non-Conformance (Client), deviation investigations, and corrective action tracking.
• Collaborate with Supplier Quality, Manufacturing Engineering, and Production teams to resolve quality issues and support ongoing manufacturing operations.
• Collect, analyze, and document quality metrics, validation results, and production data.
• Assist with internal audits, compliance initiatives, and continuous improvement projects.
• Support manufacturing process transfers, equipment qualifications, and product transition activities.

Skills

CAPA management

NCR handling

Quality documentation

Process validation

Regulated environments

Problem-solving

Organizational skills

Tools

QMS software

Job description

Job Description: Provide quality and manufacturing support for production operations, supplier quality, validation, and process improvement initiatives. This role will assist with manufacturing transfers, quality system compliance, and continuous improvement efforts within a regulated production environment.

Responsibilities

• Support daily manufacturing quality activities and ensure compliance with established quality standards.
• Assist with process validation, verification activities, and production readiness initiatives.
• Perform inspections, maintain quality documentation, and support process monitoring activities.
• Participate in CAPA, Non-Conformance (Client), deviation investigations, and corrective action tracking.
• Collaborate with Supplier Quality, Manufacturing Engineering, and Production teams to resolve quality issues and support ongoing manufacturing operations.
• Collect, analyze, and document quality metrics, validation results, and production data.
• Assist with internal audits, compliance initiatives, and continuous improvement projects.
• Support manufacturing process transfers, equipment qualifications, and product transition activities.

Requirements:

• 2+ years of experience in Manufacturing Quality, Quality Assurance, Supplier Quality, Process Quality, or Validation.
• Hands-on experience with CAPA, NCRs, quality documentation, inspections, and audit support.
• Familiarity with manufacturing quality systems, process validation, and regulated production environments.
• Strong documentation, organizational, and problem-solving skills.

Preferred Qualifications:

• Experience in the medical device or other regulated manufacturing industry.
• Exposure to manufacturing transfers, process validation, supplier quality, or new product introduction (NPI) activities.
• Experience with respiratory care, ventilator, CPAP, sleep therapy, or similar healthcare products is a plus.