Quality Assurance Manager

The Quality Assurance Manager role at RenyMed is a strategic, hands-on leader who will lead the quality function, ensuring compliance with ISO 13485 , FDA , GMP , and customer requirements. Additionally, this role drives quality strategy, operational excellence, and continuous improvement while developing a high‑performing quality team.

Responsibilities

• Maintains an effective, audit‑ready Quality Management System.
• Ensures compliance with ISO 13485, FDA QSR, GMP, and ISO 14971.
• Leads internal, supplier, customer, and regulatory audits.
• Serves as primary contact for regulatory agencies and customer quality teams.
• Supervise in‑process and final inspections to ensure product conformity.
• Uses SPC, capability studies, and quality tools to monitor performance.
• Leads CAPA, root cause analysis, and nonconformance investigations.
• Ensures quality is integrated into design and manufacturing processes.
• Leads IQ/OQ/PQ validation for equipment, processes, and products.
• Maintains risk management files and FMEAs.
• Ensures complete documentation and traceability.
• Apply Lean and Six Sigma methods to reduce defects and improve efficiency.
• Leads cross‑functional improvement projects using data‑driven decision‑making.
• Manages supplier audits, corrective actions, and performance metrics.
• Leads customer complaint investigations and ensures timely resolution.
• Build strong relationships with customers and suppliers.
• Supervises and develops the Quality Supervisor, Inspectors, Validation Engineer, Quality Engineer, and Document Control Specialist.
• Builds a culture of accountability, collaboration, and continuous learning.
• Partners with Engineering, Production, Tooling, HR, Sales, and Customer Service.
• Supports new product development from design through production.
• Facilitates communication to resolve issues and drive improvement.
• Ensures OSHA compliance and promotes safe work practices.
• Identifies risks and implements preventive measures.

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field (advanced degree preferred).
• Experience in medical devices or injection molding.
• Preferred certifications: CQE , Six Sigma , ISO 13485 Lead Auditor .

Technical & Behavioral Competencies

• Strong analytical and statistical problem‑solving skills.
• Excellent communication and cross‑functional influence.
• High attention to detail and documentation accuracy.
• Strong project management and prioritization abilities.