Senior Quality Systems Specialist

Key Responsibilities

• Support and improve the Quality Management System, including procedures, work instructions, records, document control, training support, audit readiness, and controlled quality documentation.
• Care for quality records from initiation through closure, including nonconformances, deviations, investigations, corrective actions, and preventive actions.
• Enhance closure discipline, ownership clarity, and effectiveness of corrective actions through structured problem-solving methods and practical follow-up.
• Partner with Operations, Engineering, and related functions to strengthen process control, change control, traceability, and standard work.
• Review and support controlled documentation such as SOPs, work instructions, specifications, inspection plans, validation-related documents, and quality records.
• Help maintain calibration and measurement-system discipline where applicable.
• Support internal, customer, and third-party audits through preparation, document retrieval, response support, and follow-up actions.
• Aid in customer quality investigations and responses by helping ensure facts are clear, records are complete, and corrective actions are credible.
• Support training efforts related to quality procedures, defect awareness, traceability, material handling, and document compliance.
• Help develop practical dashboards and reporting for recurring quality issues, CAPA aging, audit findings, scrap/rework themes, and related metrics.
• Convert recurring issues and transformation needs into clearer procedures, templates, workflows, and quality controls that are easier for the organization to follow.

Qualifications

• 5+ years of experience in quality assurance, quality systems, compliance, or manufacturing quality in a regulated or controlled production environment.
• Experience with CAPA, deviations, nonconformances, investigations, change control, document control, and training systems.
• Strong written documentation skills, including SOPs, work instructions, audit responses, and investigation records.
• Familiarity with root cause analysis and corrective action methods.
• Ability to work cross-functionally with Operations, Engineering, and other teams to drive follow-through.
• Hands-on comfort in a manufacturing environment and ability to connect systems work to floor execution.
• Organizational discipline and attention to detail.
• Experience with QMS, ERP, or workflow systems (nice to have).
• Experience in printing, converting, card manufacturing, packaging, or another high-mix controlled manufacturing environment (nice to have).
• Familiarity with ISO 9001, ISO 14298, ISO 13485, or similar quality systems (nice to have).
• Experience with calibration systems, traceability controls, or product/process release documentation (nice to have).
• Experience helping standardize records, templates, and site procedures during periods of operational change (nice to have).