Design Control Specialist - Sterling Engineering : Job Details

Job Title: Design Control Specialist Medical Devices

Department: Quality

Location: Schaumburg, IL (Onsite)

Job Type: Contract (Hourly Rate: $60$70/hour)

Job Summary

We are seeking an experienced Design Control Specialist with strong expertise in managing and executing the Design Control process for medical devices from start to finish. This onsite role will require a hands-on professional to train cross-functional teams, assess departmental knowledge, and implement procedural updates to streamline workflows while ensuring compliance with regulatory requirements.

Key Responsibilities

Design Control Execution: Lead and manage the Design Control process throughout the product development lifecycle, ensuring compliance with medical device regulations.

Cross-Functional Collaboration: Partner with teams across project management, marketing, quality, operations, and warehouse to clarify their roles in the process and drive alignment.

Hands-On Training: Deliver department-specific training to enhance understanding of the Design Control process and identify knowledge gaps.

Procedural Updates: Evaluate and update procedural documents to improve workflow efficiency and ensure consistent implementation.

Quality Controls: Establish and maintain robust quality controls to sustain the Design Control process.

Knowledge Assessment: Assess and document each departments understanding of the process and identify areas for improvement.

Regulatory Compliance: Ensure adherence to FDA and ISO standards for medical devices throughout the development process.

Qualifications

Required Experience:

Extensive experience executing the Design Control process from start to finish.

Medical device industry experience preferred; automotive product development experience may be considered.

Previous roles such as Medical Device Project Manager or R&D Quality Professional strongly preferred.

Skills:

Deep knowledge of Design Control processes and regulatory standards (e.g., FDA, ISO).

Strong communication and training skills to work effectively across teams.

Expertise in quality systems and procedural development.

Education:

Bachelor's degree in Engineering, Quality Management, or a related field is preferred.

Position Details

Job Type: Contract role, onsite in Schaumburg, IL.

Compensation: $60$70/hour, based on experience and qualifications.

Reports To: This position will report through the Quality department.

Application: If you are an experienced professional with a passion for quality and design controls, we encourage you to apply and contribute to our mission of delivering innovative and compliant medical device solutions