Senior Quality Engineer

Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway— you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Job Scope

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. Responsible for identifying, documenting, assessing, correcting and presenting quality issues using risk and root cause analysis tools. Supports quality of established products being sold to the market to ensure product and process conformance to global standards (including FDA and ISO

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. This includes 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.

Responsibilities

• 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.
• Collaborate with external design partners (e.g., supplier in Colombia) to review and approve digital surgery implant and instrument designs prior to manufacturing transfer.
• Provide 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.
• Monitor and audit 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.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution using a risk-based approach.
• Provide 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; develop recommendations based on data analysis. Quality Review and Management Review support.
• 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; develop recommendations based on data analysis.

Qualifications

• 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 years of experience in quality assurance in a regulated environment.
• Direct experience working with implantable medical devices preferred.
• Direct experience working with digital surgery and custom medical devices preferred.
• Familiarity with Software as a Medical Device (SaMD) principles and software lifecycle processes including verification and validation.
• Minimum 3 years of experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, EU Medical Device Regulation, etc.).
• Experience with CAPA and failure investigation / root cause analysis tools and techniques.
• Strong technical writing skills.
• Proficient in quality and statistical analysis tools (e.g., 6 Sigma, Risk Analysis, FMEA, DOE, Hypothesis Tests, trend analysis, etc.)
• Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives and external partners.
• Proven track record of strong teamwork and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
• Working knowledge of ERP Systems (SAP preferred) and Microsoft Office. Expert at Microsoft Excel and experience with Minitab
• Understanding of and experience with GD&T.
• ASQ Certified Quality Engineer preferred.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law .

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.