Quality Assurance Engineer

Quality Assurance Engineer

Department: Quality

Reports to: Manager, Quality Assurance

CeQur Corporation develops and commercializes a convenient, discrete, and simple-to-use wearable insulin delivery device that easily integrates into patients' daily lives. CeQur Simplicity is a 4 Day Insulin Patch designed to revolutionize insulin delivery and simplify the lives of people with diabetes by providing injection free dosing. CeQur Simplicity is FDA cleared.

At CeQur, we aim to provide solutions for people with diabetes that are profoundly simple and clinically effective. We are gaining tremendous momentum already and have built a leadership team and board that comprises of accomplished and respected industry experts. We are looking for like-minded A+ team players to join our team to help make a difference and build a legacy while driving penetration of our therapies. CeQur values a collaborative and creative mindset, where each team member is encouraged to contribute to our processes, decisions, planning and company culture.

Position Overview:

The Quality Assurance Engineer is responsible for ensuring the quality, safety, and compliance of the CeQur Simplicity product line by supporting design control, risk management, manufacturing, supplier management, and post-market activities.

Key Responsibilities and Essential Functions:

Support and maintain the QMS in compliance with FDA 21CFR820, ISO 13485, and other applicable regulatory requirements.

Collaborate with cross-functional teams, including R D, Operations, Marketing, and Suppliers to ensure quality and compliance throughout the product lifecycle.

Participate in design control activities, including risk management, verification and validation, and design reviews.

Update, review, and maintain Design and Development Files.

Review and approve quality records such as nonconformances, deviations, complaints, change orders, and validation documentation.

Support supplier quality management including audits and supplier qualifications.

Assist in the preparation and execution of internal and external inspections and audits (e.g., FDA, ISO).

Conduct root cause investigations and implement effective Corrective and Preventive Actions (CAPA).

Lead or participate in continuous improvement projects to enhance product quality and process efficiency.

Monitor and analyze quality metrics to identify trends and drive improvements.

Background Requirements and Qualifications

BS in Engineering; Master's in Engineering preferred.

3+ years in a Quality Engineering department for the development/manufacture of medical devices. o Experience with wearable or combination products is preferred.

CeQur Corporation 355 S Main St, 1st and 2nd Floor Greenville, SC 29601

www.myceqursimplicity.com Email: ...

Deep knowledge of FDA 21CFR820, ISO 13485, and relevant regulations/ standards.

Basic knowledge and proficiency in the application and principles of Quality Engineering and Validation.

Good understanding of Quality Management Systems, design control, risk management, and related risk management tools (e.g., FMEA, fault tree analysis, etc.)

Strong verbal and written communication skills.

Self-motivated, team-oriented, analytical, and detail-oriented.

Comfortable working in an extremely dynamic and fast paced environment.

CeQur Corporation 355 S Main St, 1st and 2nd Floor Greenville, SC 29601

www.myceqursimplicity.com Email: ...