Associate Director, Quality Systems & Compliance - Purchasing Controls - Remote

Overview

The Associate Director will lead initiatives to enhance Quality Management Systems related to Purchasing Controls and Supplier Management, ensuring compliance with regulatory standards and driving continuous improvement.

In Short

• Lead initiatives in Quality Management Systems (QMS) for Purchasing Controls.
• Collaborate with cross-functional teams to improve operations.
• Ensure compliance with cGMP and regulatory standards.
• Manage supplier evaluations, audits, and performance monitoring.
• Integrate supplier management activities across product lifecycles.
• Conduct Quality/Compliance Risk Assessments.
• Support development of supplier device specifications.
• Utilize electronic systems for quality management.
• Participate in addressing quality issues related to medical devices.
• Foster collaboration within diverse teams.

Requirements

• B.S. in Science or Engineering with 8+ years of experience.
• In-depth knowledge of medical device regulations (FDA, EU MDR, ISO).
• Experience in Supplier Quality Management and auditing.
• Strong organizational and multitasking skills.
• Effective communication and teamwork abilities.
• Experience with Quality Management Systems.
• Ability to identify gaps in QMS documents.
• Knowledge of medical device design and manufacturing processes.
• Experience in authoring and reviewing QMS documents.
• Ability to build relationships in a team environment.

Benefits

• Bonus eligibility and long-term incentives.
• Health care and insurance benefits for employees and families.
• Retirement benefits.
• Paid holidays, vacation, and sick days.
• Inclusive work environment with equal opportunities.