Principal Quality Engineer

Job Description

We are seeking an experienced quality engineer to support a strategic separation project focused on harmonizing and updating software development procedures for a global Orthopedics Medical Device organization. The contractor will partner with Quality, Regulatory Affairs, Software Engineering, Product Security, Clinical, and Program Management stakeholders to support the consolidation and standardization of the Software Development Lifecycle (SDLC) framework. The contractor will be responsible for supporting the Quality Engineering Lead by managing the quality deliverables of the program, assessing existing procedures, facilitating review of future-state processes, managing stakeholder alignment, and partnering with the technical writers to deliver an updated set of software development procedures, work instructions, templates, and implementation plans necessary to support an independent quality management system following organizational separation activities.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Experience

• Minimum 10+ years of experience in regulated medical device software development.

• Demonstrated experience executing or implementing IEC 62304-compliant development processes.

• Experience supporting FDA, MDSAP, EU MDR, and ISO 13485 audits.

• Experience with process harmonization or separation activities.

• Experience working with Class II and/or Class III medical devices.

Required Expertise

Strong working knowledge of:

• IEC 62304

• FDA Software Guidance

• FDA Design Controls

• FDA QMSR / 21 CFR Part 820

• ISO 13485

• ISO 14971

• EU MDR

• MDSAP

• Medical device cybersecurity requirements

• Design Control processes

• Computer System Validation principles

• Software risk management