Quality Compliance Specialist

Westfall Technik•Ansonia, CT

1d•Onsite

About The Position

The Quality Compliance Specialist manages and maintains the document control system, ensuring documents comply with established quality management systems and customer and regulatory requirements. The role supports internal and external audits and assists with and drives root cause analyses. The specialist collaborates with engineering, quality, and operations teams to maintain document integrity and availability. The position serves as the primary contact for controlled document storage, access, retrieval, and reference; maintains the IQMS document control system, templates, logs, and revision control; and ensures appropriate versioning, archiving, review, and distribution of controlled documents. It supports documentation for production and sample run start-ups, routes documents for approval, notifies personnel of changes, and provides training on document control procedures and IQMS. The specialist creates fixture numbers, helps develop and implement document-related SOPs, and conducts the final review and archiving of Device History Records (DHRs). The role also supports audit preparation and follow-up, maintains the internal audit program, and tracks timely closure of audit actions. It supports structured problem-solving and corrective and preventive actions (CAPAs), ensuring appropriate root cause analysis, implementation, and effectiveness checks. The position maintains organized digital and physical document libraries and indexes, supports document-control improvements, coaches teams on document management and quality compliance, provides documentation and audit trails, and performs administrative and other assigned duties. The work is usually in an office within a manufacturing facility with low to moderate noise. The employee must be able to work with others in person or remotely, as well as independently. Physical duties include regularly standing, walking, sitting, using hands and fingers, reaching, and talking or hearing, and occasionally lifting up to 25 pounds. Reasonable accommodation may be made for individuals with disabilities.

Requirements

High school diploma or equivalent.
At least 5 years of operations quality or compliance experience in a regulated industry.
Experience supporting quality compliance audits.
Working knowledge of ERP systems.
Experience managing controlled documents.
Working knowledge of reviewing engineering drawings.
Ability to work well with others one-on-one, remotely, by video, and by phone.
Ability to work independently.
Ability to meet the role’s physical demands, including occasionally lifting up to 25 pounds, with reasonable accommodation as applicable.

Nice To Haves

Associate degree in science or equivalent education.

Responsibilities

Serve as the primary point of contact for controlled document storage, access, retrieval, and reference.
Maintain the IQMS document control system, including templates, logs, and revision control.
Archive obsolete documents and maintain proper versions of controlled quality procedures, work instructions, forms, and logs.
Review documents for alignment with current standards and practices.
Distribute controlled printed copies and ensure they are removed or updated when revisions are released.
Collaborate with project managers, engineers, and the quality team to prepare documentation for new production or sample run start-ups.
Notify affected personnel of document changes using standardized templates and workflows.
Provide training and support on document control procedures and IQMS systems to internal teams and external stakeholders.
Manage documentation routing and approvals throughout the organization.
Create fixture numbers for quality and production systems.
Assist in developing and implementing SOPs for document creation, revision, and archival.
Conduct the final review and archive of Device History Records (DHRs).
Support internal and external audit preparation and activities, and help address audit observations.
Maintain the internal audit program, including approved schedules, auditor assignments, and completed reports.
Ensure timely closure of open audit actions.
Support structured problem-solving using tools such as 8D, 5 Whys, and Fishbone analysis.
Track, verify, and sustain corrective and preventive actions (CAPAs), ensuring sound root cause analysis, appropriate actions, and effective verification checks.
Maintain secure, traceable, and accessible digital and physical document libraries.
Develop and support initiatives to improve legacy and current document control systems.
Maintain filing systems and document indexes for audits and compliance reviews.
Coach internal teams on document management, document control systems, and quality, customer, and regulatory compliance requirements.
Provide requested documentation and audit trails for internal and external audits.
Perform administrative duties such as scanning, filing, template updates, and scheduling document review cycles.
Perform other assigned duties and projects and take on additional responsibilities to support team and operational priorities.