Quality Compliance & Document Control Specialist

Westfall Technik, LLC; Ansonia (CT); On-site; USD 65,000 - 95,000; Full time

Job summary

Westfall-Technik is seeking a Quality Compliance Specialist to manage our IQMS document control system and ensure alignment with quality management standards. You will support internal and external audits, drive root cause analyses, and collaborate with engineering, quality, and operations to maintain document integrity and accessibility.

Ideal candidates will have at least 5 years of experience in a regulated environment, strong knowledge of ERP systems, and experience managing controlled

Qualifications

• Minimum of 5 years of operations quality or compliance experience in a regulated industry.
• Experience in supporting quality compliance audits.
• Working knowledge of ERP systems.
• Experience managing controlled documents.
• Working knowledge of reviewing engineering drawings.

Responsibilities

• Document Control & Compliance: manage controlled document storage, access, retrieval, and reference.
• Archive obsolete documents and ensure proper versioning for Quality Procedures, Work Instructions, Forms, and Logs.
• Review documents to ensure alignment with current standards and practices.
• Collaborate with project managers, engineers, and the quality team to prepare documentation for new production or sample run start-ups.
• Provide training and support on document control procedures and IQMS systems.
• Audit Support: assist in audit preparation and auditing activities; address audit observations.
• Root Cause Analysis & Corrective Action: support 8D, 5 Whys, Fishbone; track and verify CAPAs.

Skills

Quality compliance

Document control

Audit support

Cross-functional collaboration

Education

High School Diploma or Equivalency

Associate Degree in Science

Tools

IQMS

ERP systems

Engineering drawing review

Job description

Westfall-Technik is seeking a Quality Compliance Specialist to manage our IQMS document control system and ensure alignment with quality management standards. You will support internal and external audits, drive root cause analyses, and collaborate with engineering, quality, and operations to maintain document integrity and accessibility.

Ideal candidates will have at least 5 years of experience in a regulated environment, strong knowledge of ERP systems, and experience managing controlled