QA Specialist (ISO 9001)
Quality Assurance (QA) Specialist
Owings Mills, MD
Full-Time / On-site
We are seeking a Quality Assurance Specialist with a strong ISO 9001 background and excellent communication skills to join our team. This role will play a key part in supporting our Quality Management System (QMS) and ensuring compliance across cleanroom operations. The ideal candidate will have 23 years of experience in a quality role within an ISO-certified environment and be comfortable interacting with customers in a professional, articulate manner.
Key Responsibilities
- Support and maintain the company's Quality Management System (QMS) in compliance with ISO 9001 standards.
- Conduct inspections, audits, and documentation reviews to ensure adherence to quality procedures.
- Assist with corrective and preventive action (CAPA) activities and follow up on non-conformance reports.
- Participate in internal and external audits, including preparation and coordination of audit materials.
- Collaborate with production and engineering teams to ensure quality standards are maintained in cleanroom environments.
- Review and maintain quality records, calibration logs, and validation documentation.
- Contribute to continuous improvement initiatives across processes, systems, and documentation.
- Interface directly with customers on quality-related issues, demonstrating professionalism and strong communication skills.
- Support training efforts related to quality procedures and ISO standards.
Qualifications
23 years of experience in Quality Assurance or Quality Control within an ISO 9001-certified environment.Experience working in or around cleanroom environments.Strong understanding of QMS principles and familiarity with ISO documentation requirements.Excellent verbal and written communication skills; must be comfortable interacting with customers and internal teams.Detail-oriented, organized, and capable of managing multiple priorities in a fast-paced setting.Proficient with Microsoft Office Suite (Excel, Word, Outlook).Experience using ISO management software (e.g., Core, MasterControl, or similar) is a plus but not required.Preferred Qualifications
Associate's or Bachelor's degree in a technical, engineering, or quality-related field.Experience supporting external audits or third-party certifications.Familiarity with cleanroom protocols or GMP practices.$60,000 - $70,000 a year