Quality Systems Engineer III

Principal Roles and Responsibilities

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

• Previous Medical Device Experience
• Preferred experience with SaMD (Software as a medical device) and class II medical devices.

Education & Experience

• 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.