Manage Quality for medical equipment in a hybrid setting. Oversee compliance, regulatory issues, and continuous improvement projects while ensuring customer satisfaction.
Responsibilities
Manage the quality and compliance for applicable products and processes
Ensure quality and regulatory compliance with applicable regulations
Act as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations
Manage complaints and develop new approaches to solve problems
Identify and manage the execution of continuous improvement projects
Assist in the planning of design, testing, inspection, and process validations
Ensure all quality issues are resolved to customer satisfaction in a timely manner
Requirements
Bachelor’s degree in Engineering, Science, or Technical Field
At least 4 years of experience related to the design/operation of medical device or drug combination product platforms
Knowledge of QSR/GMP/ISO requirements or other regulated industries
Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR)
Proficiency in analyzing and reporting data
Advanced level skill in Microsoft Excel
Position requires travel up to 25% of the time for business purposes
Benefits
health insurance
life and disability
401(k) contributions
paid time off
continuing education & training
Job title
Manager of Quality – Durable Medical Equipment Post Market
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