Job Description

Principal Specialist, Quality Management Systems

12-month Contract

On-site Cary, IL

Must be able to work on a W2

We are seeking a Principal Specialist, Quality Management Systems with strong knowledge of US and International Medical Device Regulations, including MDSAP, and experience with US 510(k) and EU Class II devices. The role involves ensuring compliance, managing quality systems, supporting cross-functional teams, driving projects, and providing actionable insights from data. Excellent communication, problem-solving, and technical writing skills are required.

Responsibilities:

• Plan, organize, and implement multiple concurrent tasks.
• Effectively communicate up, down, and across different levels of the organization.
• Work in cross-functional team environments.
• Make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.
• Act with a customer service/stakeholder-focused approach.
• Leverage excellent interpersonal skills to achieve desired outcomes.
• Travel as required.

Qualifications:

• Bachelor's degree in Engineering or Scientific discipline and 5+ years of experience in quality management or systems.
• Strong knowledge of US and International Medical Device Regulations, including US 510(k), EU Class II, and MDSAP.
• Strong understanding of Quality Systems, including Design & Development, Production & Service Controls, Purchasing, Adverse Event Reporting, and Continuous Improvement.
• Expert in regulatory requirements, standards, audits, and compliance risk management.
• Excellent communication, analytical, problem-solving, negotiation, and project management skills.

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