Senior Quality Engineer: Medical-Device Design & Validation

Owens & Minor; México; On-site; MXN 420,000 - 700,000; Full time

Job summary

Owens & Minor is a global healthcare solutions company focused on delivering essential products and services to hospitals and research centers. The Quality Engineer III provides advanced support for new-product development and post-market activities, leading projects and applying Lean and Six Sigma to improve quality and process performance.

Role involves cross-functional collaboration, validation planning, and ensuring compliance with medical-device regulations.

Qualifications

• Bachelor’s degree in Microbiology, Engineering, Sciences, Quality, or related technical discipline.
• 5+ years of progressive experience in product development, Quality Engineering, or related technical work within a medical-device or similarly regulated environment.
• 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.
• 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.
• Ability to communicate technical issues, risks, and recommendations clearly to cross-functional partners and leadership.
• 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.

Responsibilities

• 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 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 investigations of product, process, manufacturing, and Quality issues and applies appropriate root-cause analysis and problem-solving methodologies.

Skills

Quality Engineering

Design controls

Risk management

Validation

Change control

Statistical methods

Project leadership

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in Microbiology, Engineering, Sciences, Quality, or related discipline

Tools

Microsoft Office

Job description

Owens & Minor is a global healthcare solutions company focused on delivering essential products and services to hospitals and research centers. The Quality Engineer III provides advanced support for new-product development and post-market activities, leading projects and applying Lean and Six Sigma to improve quality and process performance.

Role involves cross-functional collaboration, validation planning, and ensuring compliance with medical-device regulations.