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Acumed · 16 hours ago

Senior Quality Engineer

Addison, TX

Full-time

Onsite

Senior Level

5+ years exp

Acumed LLC is part of the global industrial organization Marmon Holdings, committed to making a positive impact on the world. The Senior Quality Engineer is responsible for providing Quality Assurance support for all quality activities related to the development and lifecycle management of digital surgery devices and custom implants, ensuring compliance with global standards.

Health CareManufacturingMedical Device

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

Qualification

Quality AssuranceSoftware as a Medical DeviceISO 13485CAPAStatistical Analysis ToolsERP SystemsGD&TASQ Certified Quality EngineerTechnical Writing

Required

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