Quality Assurance Specialist

Science; Durham (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Science Corporation is a clinical stage technology company developing implantable devices aimed at restoring vision, cognition, and mobility. The QA Specialist will perform inspections and testing throughout manufacturing, maintain QMS records, and support CAPA initiatives to ensure product quality and compliance.

The role requires 2+ years in quality control, a 2+ year diploma/degree in quality or related field, and proficiency in English and French.

Qualifications

• 2+ years in quality control, preferably in medical devices
• Diploma/degree in quality or related field
• Professional proficiency in English and French

Responsibilities

• Perform incoming, in-process, and final inspections of components and finished products
• Conduct dimensional, visual, and functional testing
• Document inspection and test results in the QMS
• Identify non-conforming products and initiate corrective actions
• Manage the Materials Review Board (MRB)
• Inspect product returns and ensure traceability
• Adhere to GMP and quality procedures
• Prepare inspection reports, test records and batch release docs
• Support internal audits and regulatory inspections
• Assist CAPA investigations and quality improvements

Skills

Quality control

Documentation

Problem solving

English & French

GMP knowledge

Education

Diploma/degree in quality or related field

Tools

Measurement equipment

Job description

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

The Quality Assurance Specialist will support efforts to ensure the quality and conformity of our implantable product throughout the manufacturing process. The QA Specialist will perform quality inspections, in-process controls, and finished product testing in accordance with established procedures and specifications; additionally, the Specialist will maintain accurate documentation and contribute to continuous improvement initiatives within the Quality Management System (QMS). The ideal candidate thrives in a dynamic production environment and can seamlessly shift between routine inspection activities and problem-solving support for non-conformance investigations.

Role responsibilities:

• Perform incoming, in-process, and final inspections of medical device components and finished products according to established procedures and specifications
• Conduct dimensional, visual, and functional testing using appropriate measurement equipment and test methods
• Document all inspection and test results accurately in the Quality Management System
• Identify and report non-conforming products, initiating appropriate corrective actions
• Management of the Materials Review Board (MRB)
• Receipt and inspection of product return
• Follow current Good Manufacturing Practices (GMP) and company quality procedures
• Complete all required documentation including inspection reports, test records, and batch release documentation
• Participate in internal audits and support external regulatory inspections
• Ensure traceability of materials and products throughout the manufacturing process
• Maintain cleanliness and organization of inspection areas
• Pest control management
• Identify opportunities for process improvements and quality enhancements
• Participate in CAPA (Corrective and Preventive Action) investigations
• Contribute to the development and revision of quality control procedures
• Support validation and verification activities as needed
• 2+ year diploma/degree (e.g. BTS/DUT) in quality, industrial processes, or related technical field, or equivalent experience
• 2+ years of experience in quality control, preferably in medical device or pharmaceutical manufacturing
• Professional proficiency (written and verbal) in English and French

Preferred qualifications:

• Knowledge of ISO 13485 and medical device regulatory requirements
• Experience with implantable medical devices or Class III medical devices.

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local laws.