Quality Systems Engineer III

Responsible for

Ensure compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).

What You Can Expect

Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.

How You'll Create Impact

• Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards.
• Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements.

Expected Areas of Competence

• Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
• Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).
• Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory).

Preferred Experience

• With enterprise quality systems and ERP systems (e.g., SAP, EtQ).
• With SaMD (Software as a medical device) and class II medical devices.

Requirements

• Your Background
• Education/Experience Requirements
• High school diploma or equivalent required.
• Bachelor's degree in Engineering preferred.
• Technical, engineering, and/or scientific background is strongly preferred.
• Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required.
• CQE or equivalent certification preferred.
• Must be familiar with Microsoft Office Suite.