Senior Quality Systems Specialist
About The Position
ABCorp is seeking a Senior Quality Systems Specialist to help strengthen and standardize our quality operating practices during a period of business and process transformation. This role will play a key part in improving the discipline, clarity, and consistency of our quality systems across documentation, investigations, corrective actions, audits, training, and process change. This is a high-impact specialist role for someone who is strong in quality systems execution and cross-functional follow-through. The position will help ABCorp move from reactive issue handling toward more consistent, scalable process control by building better structure, stronger records, and more effective quality routines.
Requirements
- 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
- Experience supporting internal and external audits
- 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
- Strong organizational discipline and attention to detail
- Experience with QMS, ERP, or workflow systems
Nice To Haves
- Experience in printing, converting, card manufacturing, packaging, or another high-mix controlled manufacturing environment
- Familiarity with ISO 9001, ISO 14298, ISO 13485, or similar quality systems
- Experience with calibration systems, traceability controls, or product/process release documentation
- Experience helping standardize records, templates, and site procedures during periods of operational change
Responsibilities
- Support and improve the Quality Management System, including procedures, work instructions, records, document control, training support, audit readiness, and controlled quality documentation.
- Coordinate and drive quality records from initiation through closure, including nonconformances, deviations, investigations, corrective actions, and preventive actions.
- Improve 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.
- Assist with 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
