Quality Systems Manager

Job Description:

• A global chemical manufacturer supporting the medical device industry is seeking a Quality Systems Manager to lead and maintain the site’s Quality Management System (QMS). This role serves as the Management Representative, partnering cross‑functionally to ensure compliance to ISO 13485, 21 CFR Part 11, and 21 CFR Part 820 while driving continuous improvement across the operation.

What You’ll Do:

• Own, maintain, and improve the Quality Management System (QMS).
• Lead internal/external audits, CAPA, non‑conformance investigations, and risk analysis (incl. FMEA).
• Manage quality inspection activities and support metrology (incl. Gage R&R).
• Develop and maintain procedures, work instructions, forms, and document control.
• Perform statistical analysis using Minitab or similar tools.
• Support PPAP, process/equipment/material validations, and failure analysis.
• Track quality metrics, lead quality goals, and deliver team training.

What You Need:

• Bachelor’s degree or equivalent experience.
• Experience in manufacturing; medical device or medical packaging preferred.
• Knowledge of ISO 13485, 21 CFR 11/820, CAPA, audits, and QMS ownership.
• Strong Excel/PowerPoint/Word skills; Minitab experience preferred.
• Excellent communication skills and ability to work independently.
• Organized, detail‑oriented, and able to lead quality system design.

Nice to Have:

• Six Sigma or continuous improvement training.
• Certified Quality Auditor (CQA).
• Bilingual English/Spanish.