Quality Assurance Manager

Quality Assurance Manager at Reny Med Quality Assurance Manager at Reny Med in Arcadia, California Posted in 2 days ago.

Type:

full-time

Job Description:

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.