Sr. Software Quality Engineer

We are seeking a Senior Software Quality Engineer to support commercial medical device manufacturing by ensuring compliance, quality, and validation of software and manufacturing processes. This role partners with Engineering and Manufacturing teams to drive quality improvements, validation activities, investigations, and regulatory compliance.

Key Responsibilities

• Support software quality and validation activities for medical device manufacturing.
• Lead and support process validation, software validation, and change control activities.
• Conduct investigations, root cause analysis, and CAPA activities.
• Develop and maintain quality documentation, protocols, and reports.
• Partner with cross-functional teams to ensure compliance with regulatory and quality requirements.
• Apply quality tools such as FMEA, SPC, DOE, and statistical analysis to improve manufacturing processes.

Must-Have Qualifications

• Experience with Computer Software Validation for manufacturing equipment and systems.
• Experience with Medical Device Change Control processes.
• Strong investigation and root cause analysis skills.
• Experience with Process Validation and software validation activities.
• Technical writing, organization, and communication skills.
• Knowledge of SPC, CAPA, NCMR, and PDP processes.
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485:2016.
• Bachelor's degree in Engineering, Software Engineering, Science, or related field plus 4+ years of experience (or Master's degree with 2+ years of experience).

Nice-to-Have

• DRM Green Belt Certification
• Six Sigma experience
• Medical device industry experience
• FMEA and DOE experience