AQE Engineer – Validation & Quality

About the role

BD is seeking an experienced AQE Engineer to lead equipment and process validation activities within its medical device manufacturing operations. The role combines hands‑on validation work with quality investigations and continuous‑improvement projects in a regulated environment.

Key responsibilities

• Lead and support equipment and process validations, developing and executing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
• Conduct quality investigations, perform root‑cause analysis and implement corrective and preventive actions (CAPA) for product and process issues.
• Support supplier quality activities, including vendor audits and regulatory compliance initiatives.
• Analyze quality trends, drive continuous‑improvement projects and partner with Manufacturing, Engineering, Suppliers and Customer Service to resolve quality concerns.
• Ensure ongoing compliance with current Good Manufacturing Practices (cGMP), ISO standards and other regulatory requirements.

Required profile

• Bachelor’s degree in Engineering.
• 3‑5 years of engineering experience, preferably in medical‑device manufacturing.
• Strong experience with equipment and process validations (IQ, OQ, PQ).
• Proven ability to lead projects and work within cross‑functional teams.
• Knowledge of cGMP, ISO standards and regulated manufacturing environments.
• Excellent verbal and written communication skills; bilingual in Spanish and English.

Required skills

• Equipment validation
• Process validation
• IQ/OQ/PQ protocol development
• Root cause analysis
• CAPA implementation
• cGMP compliance
• ISO standards (e.g., ISO 13485)
• Supplier audit

What we offer

• Opportunity to work on cutting‑edge medical‑technology products.
• Collaborative, purpose‑driven culture focused on learning and growth.
• Access to global resources and continuous‑improvement initiatives.