Job Overview
The Quality Manager role is a leadership position responsible for ensuring the site meets and exceeds business and quality plans. As a key member of our team, you will provide technical guidance, structure, and leadership for the Quality function.
Main Responsibilities:
* Evaluate and ensure compliance of quality systems with QSR and current pertinent regulations (e.g., FDA, ISO). Foster awareness of regulatory requirements and quality management system standards to drive improvements in overall quality and compliance.
* Participate in internal audits, identifying and analyzing non-conformances and related trends.
* Promote issue escalation to Senior Management for corrective and preventive action, driving business improvement.
* Support training management processes, lead implementation of Quality improvement projects, and contribute to Lean initiatives within the Quality function and broader business operations.
* Provide technical leadership, participate in Engineering drawing interpretation, and support measurement system analysis processes.
* Lead statistical analysis initiatives to identify trends, reduce variability, and enhance product and process quality.
Requirements:
* A Bachelor's degree in a scientific discipline is advantageous.
* Minimum 5 years of quality management experience or equivalent in the medical device industry and/or FDA-regulated environment.
* Experience in people leadership roles (at least 3 to 5 years).
* Demonstrated knowledge of Quality Assurance, excellent communication skills, and analytical problem-solving abilities.
* Ability to collaborate with cross-functional teams to ensure business success and compliance.
Key Skills:
Regulatory & Quality Systems Expertise, Statistical & Analytical Skills, Quality Assurance Leadership in Medical Devices.