Senior Quality Engineer – Medical Device Manufacturing

About the role

This position is part of the Operation Quality team supporting the launch of a new manufacturing site in Costa Rica. You will help transfer equipment, processes, and product implementation while ensuring compliance with quality standards and regulatory requirements.

Key responsibilities

• Evaluate process methods and equipment to meet performance and quality requirements.
• Establish and maintain quality plans for equipment and processes.
• Monitor process performance against defined standards.
• Apply ISO and QSR requirements to internal processes and supplier activities.
• Collaborate with suppliers on new product introductions to ensure quality and performance criteria are met.
• Assist Manufacturing, Sourcing, and Development teams in interpreting and applying regulations.
• Develop and maintain department and project budgets.

Required profile

• B.S. in Engineering or equivalent degree.
• Certification as a Quality Engineer (e.g., CQE) or Reliability Engineer (CRE) preferred.
• 5‑7 years of experience in Quality Engineering, preferably in the medical‑device industry.
• Ability to travel up to 20% (up to 50% for supplier‑focused roles).

Required skills

• ISO standards compliance
• QSR (Quality System Regulation) knowledge
• Use of Quality Management System (QMS) tools
• Audit and inspection techniques
• Budget development and management

What we offer

• Development opportunities and employee resource groups
• Flexible working environment
• Competitive total rewards and wellness incentives
• Culture of recognition and performance awards