Owens & Minor is a integral 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 provides advanced Quality Engineering support for new-product development, existing products and processes, design controls, risk management, validation, and post-market activities. The role independently executes complex technical work, leads defined Quality Engineering projects and workstreams, and partners across functions to ensure product and process changes meet applicable Quality, regulatory, and business requirements.

- Provides advanced Quality Engineering expertise in support of new-product development, existing products, manufacturing processes, product changes, and process changes.
- Develops, coordinates, and executes validation activities required to support medical-product manufacturing and distribution.
- Provides subject-matter expertise in process validation, product and material changes, design controls, risk management, and related Quality-system activities.
- Supports development and execution of deliverables required for medical-device change control and product-development activities.
- Participates in product-development planning and provides Quality Engineering support for design reviews, quality plans, design transfer, design verification, and validation activities.
- Partners with cross-functional project teams to incorporate Quality-system requirements, root-cause analysis, corrective action, risk management, and continuous-improvement principles throughout the product lifecycle.
- Ensures assigned product-development and business-support activities comply with applicable medical-device regulations, Quality-system requirements, and internal procedures.
- Develops and supports statistical plans, technical rationale, and data-analysis approaches for change-control and process-control activities.
- Applies Lean, Six Sigma, and other continuous-improvement methodologies to investigate and resolve product, process, and Quality issues.




- Leads defined continuous-improvement projects or technical workstreams involving design controls, process validation, risk management, GPMS reviews, inspection planning, process capability, and related Quality Engineering activities.
- Analyzes Quality, manufacturing, process, and post-market data to identify trends, risks, and opportunities for improvement.
- Develops and supports implementation of Quality Engineering programs and technical solutions that improve product and process quality.
- Evaluates and recommends technologies, process improvements, and engineering controls to improve manufacturing capability, product quality, and operational performance.
- Supports and coordinates risk-management activities and ensures assigned deliverables are completed in accordance with applicable requirements.
- Supports development, review, maintenance, and updates of Design History Files and related design-control documentation.
- Reviews, approves, and maintains assigned GPMS reviews, design-history documentation, risk-management files, validation records, and other Quality-system documentation within established authority.
- Supports investigations of product, process, manufacturing, and Quality issues and applies appropriate root-cause analysis and problem-solving methodologies.
- Supports corrective and preventive action activities and provides technical input to ensure corrective actions are appropriate, effective, and supported by Quality Engineering principles.
- Provides Quality Engineering support to manufacturing facilities, supply-chain partners, and other cross-functional stakeholders.
- Reviews technical data, Quality metrics, process performance, and post-market information to identify potential adverse trends and recommends appropriate actions.
- Provides technical guidance and knowledge sharing to less experienced employees and cross-functional partners within areas of expertise.
- Leads defined Quality Engineering projects, technical assignments, or workstreams and coordinates deliverables across multiple stakeholders.
- Communicates technical findings, project status, risks, and recommendations to appropriate stakeholders and leadership.




- Escalates significant product-quality, process, regulatory, or compliance concerns to the Director, Quality Engineering and other appropriate stakeholders.
- Demonstrates excellent guest service to internal team members.
- Performs other related duties as assigned.

Qualifications

- Bachelor’s degree in Microbiology, Engineering, Sciences, Quality, or a related technical discipline required.
- 5+ years of progressive experience in product development, Quality Engineering, or related technical work within a medical-device or similarly regulated environment.
- Demonstrated experience supporting product and process development.
- Experience with design controls, risk management, validation, change control, and related Quality-system activities.
- Experience supporting or leading defined technical projects or workstreams within a cross-functional environment.
- Experience analyzing technical, manufacturing, Quality, or post-market data to support decision-making and continuous improvement.
- Strong knowledge of Quality Engineering principles and practices within a regulated medical-device environment.
- Strong working knowledge of design controls, risk management, process validation, change control, and product-lifecycle Quality activities.
- Working knowledge of applicable medical-device Quality-system and regulatory requirements.
- Ability to independently evaluate complex technical information, identify risks, and develop practical recommendations.
- Strong analytical, problem-solving, root-cause analysis, and decision-making skills.
- Ability to lead defined projects and coordinate technical deliverables across cross-functional teams.
- Ability to analyze data and apply statistical and risk-management methods to support Quality Engineering decisions.
- Ability to manage multiple assignments, priorities, and project deliverables with limited supervision.
- Strong written and verbal communication skills.
- Ability to communicate technical issues, risks, and recommendations clearly to cross-functional partners and leadership.
- Ability to provide technical guidance and support to less experienced employees and business partners.
- Strong collaboration and relationship-management skills across Engineering, Manufacturing, Supply Chain, Regulatory Affairs, Quality, and other functions.
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Ability to work independently in a fast-paced, cross-functional environment.

📌 Quality Engineer III (México)
🏢 Owens u0026 Minor
📍 México