Senior Quality Engineer

Acumed LLC is a part of the global industrial organization Marmon Holdings, backed by Berkshire Hathaway. We’re committed to making a positive impact on the world, providing diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

A Senior Quality Engineer – SaMD (Software as a Medical Device) & Personalized Devices is responsible for providing Quality Assurance support for all quality activities related to the development, production, inspection and lifecycle management of digital surgery and/or custom implants, instruments, and associated software, including Software as a Medical device (SaMD) and surgical planning tools. The role involves identifying, documenting, assessing, correcting and presenting quality issues using risk and root cause analysis tools.

It supports quality of established products being sold to the market to ensure product and process conformance to global standards (including FDA and ISO 13485). In addition, the Senior Quality Engineer plays a critical role in guiding cross‑functional teams through the development and validation of software‑related medical device projects, ensuring compliance with design controls, software development lifecycle processes, and verification and validation activities to maintain the highest standards of patient safety and product performance.

• Provides quality leadership to product development teams and external partners in the areas of design control, risk management, and specification development ensuring compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.
• Collaborates with external design partners (e.g., supplier in Colombia) to review and approve digital surgery implant and instrument designs prior to manufacturing transfer.
• Provides quality leadership for digital surgery and custom implant and instrument manufacturing operations.
• Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, Health Hazard Evaluations, and Risk Management.
• Leads and supports quality investigations and root cause determinations; manages Non‑Conforming Material Reports and non‑conforming product dispositions.
• Creates and maintains final inspection plans and works with applicable subject matter experts to develop and validate inspection methods, as needed.
• Monitors and audits all aspects of SaMD implementation including development, configuration management, verification and validation, and transition to production.
• Collaborates with cross‑functional teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provides training, guidance, and interpretation as needed.
• Becomes familiar with the applicable technology to facilitate participation in technical discussions and risk‑based decision making; coordinates issue resolution using a risk‑based approach.
• Provides guidance and support regarding assurance activities including unscripted testing and scripted testing, ensuring robust verification and validation practices for software and hardware.
• Trends and reports on quality data in order to improve product and process; develops recommendations based on data analysis. Supports Quality Review and Management Review.
• Reviews verification and validation protocols and reports and identifies gaps for cGMP compliance. Supports the development and execution of strategies to close gaps in an efficient, technical, and compliant manner.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely manner.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to QMS processes. Leads the execution of recommended changes, as appropriate.
• Trends and reports on quality data in order to improve product and process; develops recommendations based on data analysis.

• Bachelor’s degree in an engineering or science discipline (advanced degree preferred) and minimum 5 years of experience in quality assurance in a regulated environment, or if no degree, minimum 11…