Job Title: Quality Engineer

Location: West Chester, PA

Duration: Long-term Contract

Summary:

Join Brooksource's Fortune 50 medical device client as a Quality Engineer (Cybersecurity). You'll be responsible for integrating new and updated product security QMS requirements into local business procedures, work instructions, and templates. Your role will involve recognizing opportunities for efficient process integration of MedTech product security updates into local QMS and technical documentation.

Principal Duties:

• Execute to a documented QMS Quality Plan supporting product security process updates, inclusive of but not limited to, vulnerability management, threat modeling, patch management and metrics, and other product related cybersecurity documentation.
• Work in an advanced technical and regulated environment of medical devices, data, and data systems throughout a defined and documented product lifecycle in accordance with IEC62304, ISO14971/ TR24971, AAMI TIR57, EUMDR, FDA and IMDRF cybersecurity guidance.
• Execute privacy and data lifecycle process documentation updates.
• Support the development or maintenance of software supply chain risk management processes supporting software supply chain cybersecurity, security patch development, deployment, and secure software configuration management.
• Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.

Education and Experience:

• A minimum of a Bachelor’s degree is required. An advanced degree is preferred.
• A minimum of 4 years of regulated industry experience in a quality or new product development capacity is required.
• Medical device industry experience required.
• Experience in applicable industry standards and regulations including, but not limited to IEC 62304, FDA 21 CFR 820, FDA guidance (specifically on Device Software Functions and Cybersecurity), ISO 13485, ISO 14971, IEC 80002, and IEC 62366.
• Experience with Quality Systems, Application Lifecycle Management (ALM) systems (i.e. Polarion) or PLM systems (i.e. Windchill) is preferred.

Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.