Quality Engineer III – Kitting Component Evaluation & Design Change Process

Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.
Position Summary
The Quality Engineer III – Kitting Component Evaluation & Design Change Process, provides specialized Quality Engineering support for component evaluation, design verification, risk management, and implementation of supplied components used within sterile barrier systems for convenience kits. The role independently leads defined technical projects, partners across Design Control Engineering, Sterility Assurance, Regulatory Affairs, Suppliers, Procurement, and Commercial teams, and ensures component evaluations and design changes meet applicable Quality, regulatory, and business requirements.
Responsibilities
Executes and supports component evaluation and design-change activities for supplied components used within sterile barrier systems for convenience kits.
Develops and implements improvements to component-evaluation processes, tools, documentation, and electronic repositories to support consistent execution across the kitting network.
Leads defined component-evaluation projects and technical workstreams using project-management, risk-assessment, and Quality Engineering tools.
Partners with Design Control Engineering, Sterility Assurance, Regulatory Affairs, Suppliers, Procurement, Commercial, and other cross-functional stakeholders to evaluate component requirements and support compliant implementation.
Evaluates supplied components to ensure applicable Quality, regulatory, design-verification, and sterile-processing requirements are met before implementation.
Supports the design verification process for new and existing components incorporated into sterile barrier systems.
Ensures component evaluations and associated design-change activities are executed consistently, accurately, and in accordance with applicable Quality-system and regulatory requirements.
Applies applicable regulatory requirements and standards, including QSR, GMP, ISO, MDSAP, MDR, and other relevant requirements, to component evaluation and design-verification activities.
Develops and maintains procedures, work instructions, evaluation tools, templates, and technical documentation supporting component onboarding and design-change processes.
Supports development and maintenance of electronic systems or repositories used to consolidate and manage component-evaluation records across the kitting network.
Performs and documents risk-management assessments associated with component evaluation and design verification.
Participates in Design Change Design Reviews and provides technical input regarding component evaluation, design verification, risk, and implementation requirements.
Provides Quality Engineering expertise and recommendations to support the development, manufacture, and distribution of safe, effective, and compliant products.
Reviews technical data, component specifications, supplier documentation, and Quality information to identify potential risks, gaps, or compliance concerns.
Identifies and recommends actions to resolve technical, Quality, or regulatory issues associated with component evaluation and implementation.
Coordinates technical deliverables across multiple stakeholders and ensures assigned projects progress according to established timelines and requirements.
Applies problem-solving, risk-management, and continuous-improvement methodologies to improve component-evaluation and design-change processes.
Monitors project status, identifies barriers, and recommends practical solutions to support timely and compliant execution.
Provides technical guidance and knowledge sharing to less experienced employees and cross-functional partners within areas of expertise.
Supports development of training materials and provides technical training related to component evaluation, design verification, risk management, and associated Quality processes.
Provides input to subject matter experts responsible for design controls, risk management, and related systems supporting the kitting network.
Communicates technical findings, project status, risks, and recommended actions to appropriate stakeholders and leadership.
Escalates significant Quality, regulatory, design-verification, or component-related risks to appropriate leadership.
Demonstrates excellent guest service to internal team members.
Performs other related duties as assigned.
Qualifications
Bachelor’s degree in Engineering, Sciences, Quality, or a related technical discipline required.
5+ years of progressive Quality Engineering, Design Quality, Manufacturing Quality, or related technical experience within a medical device or similarly regulated environment.
Demonstrated experience supporting component evaluation, design verification, design changes, or implementation of supplied components.
Experience applying domestic and international medical-device regulatory requirements to Quality Engineering activities.
Experience with design controls, risk management, sterility assurance, and related Quality-system requirements.
Experience leading defined technical projects or workstreams in a cross-functional environment.
Experience developing or improving technical processes, procedures, tools, or electronic repositories.
Experience working independently with limited guidance on complex technical assignments.
Strong knowledge of Quality Engineering principles and practices within a regulated medical-device environment.
Working knowledge of applicable Quality and regulatory requirements, including QSR, GMP, ISO, MDSAP, MDR, and related standards.
Strong understanding of design controls, design verification, risk management, component evaluation, and change-control processes.
Ability to independently analyze technical information, identify risks, and develop practical recommendations.
Strong project-management and organizational skills with the ability to manage multiple concurrent priorities.
Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Visio, and related project-management tools.
Ability to work independently in a fast-paced, cross-functional environment.

Work arrangement
Yes