This job has closed.

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) · 20 hours ago

Quality Engineer

Eden Prairie, MN

Full-time

Onsite

Mid, Senior Level

3+ years exp

NeuroOne Medical Technologies Corporation is seeking a Quality Engineer to implement and maintain quality systems for compliance with various regulatory standards. The role involves supporting quality assurance in the design and development of medical device products, managing supplier quality, and leading investigations related to quality issues.

BiotechnologyHealth CareHospitalMedical

Hiring Manager

Emily Johns

Responsibilities

Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 820) and other applicable standards

Quality assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of the design and development plan

Supplier Quality Management of contract manufacturers, including initial qualification, requalification, supplier corrective actions, change notification, and supplier audits

Support quality audits and regulatory inspections by FDA and Certification Bodies

Leading investigations in support of Root Cause Analysis, CAPA, and Control of Nonconforming Materials

Coordinating CAPA implementation, documentation, and effectiveness verification

Post-Market Surveillance and Post-Market Clinical Follow Up Plans and Reports

Qualification

ISO 13485FDA Quality System RegulationsManufacturing PracticesRisk ManagementRoot Cause AnalysisISO StandardsMicrosoft WordMicrosoft ExcelMicrosoft PowerPoint

Required

Excellent Quality System knowledge required

Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards

Working knowledge of principles, concepts, and practices for design and development activities, Risk Management, Root Cause Analysis, and application of ISO Standards

Proficiency in Microsoft Word, Excel, PowerPoint

Preferred

BS in Engineering, Sciences, or other applicable field, and 3 to 8 years of experience in the regulated medical device industry as a Quality Assurance Engineer (or similar) is preferred

Company

NeuroOne Medical Technologies Corporation (NASDAQ: NMTC)

NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, stimulation and ablation solutions for patients suffering from Epilepsy, Parkinson’s Disease, Essential Tremors and other related neurological disorders that may improve patient outcomes and reduce procedural costs.

Founded in 2009

Eden Prairie, Minnesota, USA

11-50 employees