Job Summary

Senior Quality Engineer ensures product and software development process conformance to applicable quality system regulations and standards. Responsible for guiding teams in execution of product life cycle activities with focus on quality planning and risk management, including cybersecurity, to positively impact the safety and efficacy of products. May be required to communicate with both clients and vendors. Often required to perform audits and maintain auditing schedule. Must have strong technical writing and communication skills.

Responsibilities

• Provides support to product development and project teams in the areas of quality management system, design control, risk management, verification and validation activities, information security, cybersecurity and data privacy.
• Participates in project core teams as the Quality representative throughout the product lifecycle.
• Supports project teams during internal and external customer and quality audits.
• Participates in process improvement opportunities.
• Applies applicable regulations and standards to manage the risk and provide solutions/ strategy.
• Develops and assists with updates of standard operating procedures and other Quality documents.
• Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

Basic Qualifications

• Demonstrated ability to quickly understand new technologies and concepts
• Strong understanding of cloud security technologies for phone applications and devices
• Outstanding oral and written communications skills
• Experience and working knowledge of FDA 21 CFR Part 820 Quality System Regulation, 21 CFR Part 11, and ISO 13485 standard.
• Experience and working knowledge of IEC 62304 and ISO 14971.
• Ability to take a risk-based approach as it relates to cybersecurity
• Required experience:
  • Medical devices (Class II/III), Software level of concern (Moderate/High)
• Communications, Interfaces, Encryption Methods, Authentication Methods, Bluetooth (BLE), Mobile Applications (Android and iOS)
• Experience with securing Azure and/or AWS
• CISSP and other security certifications i.e. CEH, ISSAP/ISSMP, CRISC, SANS
• Working knowledge and experience with the NIST Cybersecurity Framework and other standards frameworks, including SP900-213, NISTIR 8259A, NISTIR 8259B, NISTIR 8259C, NISTIR 8259D
• Working knowledge and experience with the FDA Policy for Device Software Functions and Mobile Medical Application
• Working knowledge and experience with the FDA Draft Guidance Management of Cybersecurity in Medical Devices
• Experience with cloud, mobile, SIEM, and open-source security technologies
• Experience in supporting large and complex projects
• 2+ years large enterprise experience
• Familiarity with building enterprise security strategies and roadmaps
• Experience with Enterprise Security Architecture
• Experience with cybersecurity technologies and advanced threat management solutions
• Knowledge of authentication technologies such as SAML, OAUTH
• Experience with CASB tools such as Microsoft Cloud App Security
• Experience with electronic product life cycle (PLM) and enterprise resource planning tools (ERP).
• Experience with enterprise quality system tools (e.g., electronic CAPA, Complaint Management systems).
• Intellectual curiosity and a drive to learn and grow.
• Motivated self-starter.
• Detail oriented and organized.
• Skilled in written and verbal communication.
• Influencing and negotiation skills preferred.
• Highly responsive.
• Stable and fast internet connection.
• Desired experience: Experience administering Azure AD

Education and Experience

• Bachelor's degree in Engineering, science, or technical field with 4+ years of experience in Engineering and/or Quality OR Advanced degree in Engineering, science, or technical field with 2+ years of experience in Engineering and/or Quality.
• Experience working in FDA regulated environment.
• Strong knowledge of scientific principles and concepts.
• Working knowledge and experience with Medical devices (Class II/III), Software level of concern (Moderate/High)
• Working knowledge and experience with sercuring Communications, Interfaces, Encryption Methods, Authentication Methods, Bluetooth (BLE), Mobile Applications (Android and iOS)
• Working knowledge and experience with securing Azure and/or AWS