Owens & Minor is a general 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 II provides Quality Engineering support for new-product development, existing products, manufacturing processes, design controls, risk management, validation, and post-market activities. The role independently executes defined technical assignments, analyzes Quality and process data, and partners with cross-functional teams to support compliant product development, manufacturing, distribution, and continuous improvement.

Core Responsibilities

- Executes validation activities required to support medical-product manufacturing, distribution, product changes, and process changes.
- Supports Quality Engineering deliverables associated with new-product development, product changes, manufacturing changes, and medical-device change-control activities.
- Supports global risk-management activities, including development, maintenance, review, and update of applicable risk-management documentation.
- Supports design-control activities and ensures applicable Quality requirements are incorporated throughout product-development and change-management processes.
- Participates in GPMS reviews and supports updates to applicable product, design, Quality, and risk-management documentation.
- Develops and supports execution of process-validation protocols, reports, and related technical documentation.
- Reviews and analyzes post-market, manufacturing, and supply-chain Quality data to identify trends, emerging risks, and potential adverse performance indicators.
- Supports investigations of product, process, and Quality issues and applies root-cause analysis methodologies to identify contributing factors and appropriate corrective actions.
- Supports corrective and preventive action activities and ensures Quality Engineering considerations are incorporated into investigation, remediation,



and effectiveness-verification activities.
- Partners with project teams to incorporate Quality-system requirements, risk-management principles, root-cause analysis, corrective action, and continuous-improvement practices throughout the product lifecycle.
- Participates in continuous-improvement initiatives involving design controls, process validation, risk management, GPMS reviews, inspection planning, process capability, and related Quality Engineering activities.
- Supports Quality Engineering programs designed to improve product quality, process performance, manufacturing capability, and operational effectiveness.
- Evaluates proposed product, process, manufacturing, and supply-chain changes to identify potential Quality, regulatory, validation, and risk-management impacts.
- Participates in initiatives to evaluate and implement technology, process improvements, engineering controls, and other solutions that improve product and process performance.
- Supports development, review, and maintenance of inspection plans, process controls, specifications, and Quality Engineering documentation.
- Supports updates and maintenance of Design History Files and related design-control documentation.
- Reviews technical and Quality data and provides recommendations to support product, process, and manufacturing decisions.
- Provides Quality Engineering support to manufacturing facilities, supply-chain partners, and cross-functional teams regarding product and process Quality requirements.
- Supports internal and external audit activities by providing technical documentation, Quality records, and subject-matter support within assigned areas.
- Identifies Quality, product, process, or compliance concerns and escalates significant issues to the Director, Quality Engineering and other appropriate stakeholders.
- Participates in defined Quality Engineering projects and workstreams and ensures assigned deliverables are completed accurately and within established timelines.
- Applies continuous-improvement, risk-management,



and problem-solving methodologies to assigned Quality Engineering activities.
- Provides technical guidance and knowledge sharing to cross-functional partners within assigned areas of responsibility.
- Demonstrates excellent guest service to internal team members.
- Performs other related duties as assigned.

Qualifications

- Bachelor’s degree in Engineering, Microbiology, Sciences, Quality, or a related technical discipline required.
- 3+ years of progressive Quality Engineering or related technical experience within a medical-device or similarly regulated environment.
- Experience supporting product and process development activities.
- Experience supporting design controls, risk management, process validation, change control, and Quality-system activities.
- Experience analyzing Quality, manufacturing, or post-market data to identify trends, risks, and improvement opportunities.
- Experience supporting investigations, root-cause analysis, corrective actions, and continuous-improvement initiatives.
- Experience working with cross-functional teams supporting product development, manufacturing, supply chain, or Quality activities.
- Strong working knowledge of Quality Engineering principles and practices within a regulated environment.
- Working knowledge of medical-device Quality-system and regulatory requirements.
- Knowledge of design controls, risk management, process validation, change control, and product-lifecycle Quality activities.
- Ability to analyze technical and Quality data, identify trends, and develop practical recommendations.
- Strong analytical, problem-solving, and root-cause analysis skills.
- Ability to independently execute defined technical assignments with limited supervision.
- Ability to manage multiple priorities and deliverables within established timelines.
- Strong written and verbal communication skills.
- Ability to work effectively with Engineering, Manufacturing, Supply Chain, Regulatory Affairs, Quality, and other cross-functional partners.
- Ability to interpret technical requirements and apply them to product, process, and manufacturing activities.
- Strong attention to detail and documentation accuracy.
- Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Ability to work independently in a fast-paced, cross-functional environment.

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