Senior Quality Assurance Specialist

Senior Quality Systems Specialist

The Senior Quality Systems Specialist is a key role responsible for managing and supporting the Quality Management System (QMS) in a medical device company. This includes areas such as document control, training, Corrective and Preventive Actions (CAPA), internal and supplier audits, nonconformance management, and assisting with production-related tasks.

Key Responsibilities

• CAPA Management: Oversees all CAPA processes from initiation and investigation to implementing corrective actions, verifying effectiveness, and closing CAPAs.
• Manages the internal audit schedule, leads or facilitates audits, and ensures findings are addressed and resolved. Supports external audits of the company's QMS.
• Document Control: Assists with document change control, retention, and maintenance of quality records.
• Training Administration: Coordinates onboarding training, manages training assignments, logs completed training, and maintains accurate training records.
• Quality Logs: Maintains logs for quality records, including nonconformance, CAPA, and rework logs.
• Supplier Management: Handles supplier qualification, maintains the Approved Suppliers List (ASL), manages supplier files, and oversees the Supplier Corrective Action Request (SCAR) program.
• Management Review Support: Assists the Director of QA in preparing materials for management reviews.
• Employee Guidance: Provides training and support to staff on quality processes and procedures.
• Production Quality Support: Conducts quality reviews of inspection and manufacturing device/lot history records.
• Regulatory Compliance: Ensures adherence to regulatory requirements.
• Health & Safety: Follows company health and safety policies.

Requirements

• Minimum of 5 years in quality operations within the medical device industry.
• Experience managing document control systems and training programs.
• Experience with electronic Quality Management Systems (eQMS); administration experience is preferred.

KSA

• Strong knowledge of FDA regulations (21 CFR 820), ISO 13485, and ISO 14971.
• Proficient in Microsoft Word and Excel.
• Ability to work independently.
• Excellent verbal and written communication skills.
• Strong problem-solving abilities.
• Excellent interpersonal skills with a collaborative, team-oriented mindset.

Education

• Bachelor's degree in a technical or scientific field preferred.

Physical Demands

• Activities may involve sitting, standing, or walking.
• Must be able to lift and carry up to 50 lbs.