Engineer, Quality Engineering (Healthcare)

Location: Marsa, Malta

Salary: €27,200 minimum annually, with potential eligibility for benefits, discretionary bonuses, and/or long-term incentives.

Company

hirify.global is a healthcare company focused on developing and delivering products and solutions that help save and sustain lives.

What you will do

• Support process development and process changes by ensuring effective qualification and validation in manufacturing.
• Review validation protocols and transfer methodologies for manufacturing changes and design changes.
• Lead or contribute to PFMEAs, FMEAs, risk assessments, and validation activities.
• Lead and coordinate the plant master validation plan and support data integrity requirements.
• Lead and support QC laboratory test method validation, new process validation, and equipment validation.
• Collaborate with process improvement and quality management teams to resolve manufacturing and laboratory issues.

Requirements

• Experience or capability in qualification, process validation, test method validation, and quality engineering activities.
• Knowledge of PFMEA/FMEA, risk assessment, change control, and design change transfer.
• Ability to ensure compliance with customer, regulatory, and hirify.global Quality Management System requirements.
• Ability to work in accordance with ISO 13485, good laboratory practices, and good documentation practices.
• Ability to implement corrective actions resulting from TUV, corporate, internal, or other audits within established timelines.
• Awareness of environmental, health, and safety requirements in manufacturing and laboratory activities.

Culture & Benefits

• Mission-driven healthcare environment focused on saving and sustaining lives.
• Culture emphasizing courage, trust, collaboration, ownership, and accountability.
• Potential eligibility for competitive benefits, discretionary bonuses, and/or long-term incentives.
• Equal employment opportunity and reasonable accommodation support.