R&D Documentation Specialist

Position Title: Documentation Specialist R&D

Department:  Electrophysiology

F/P Time: Full-time

Location: Cartago, Costa Rica

About Heraeus

Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and cutting-edge technologies to create products used all over the world with one thing in common: World-class quality.

JOB PURPOSE

Provide technical and purchasing support to R&D activities and manage documentation control changes, ensuring high-quality, compliant documentation for process development, validation, and manufacturing.

MAJOR RESPONSIBILITIES 

• Lead purchasing activities related to but not limited to quoting, purchasing request orders, CAPEX and shipping activities.
• Oversight process development, product engineering runs and validation activities according to quality procedures.
• Create, update and release manufacturing procedures, drawings and engineering reports.
• Create, route and complete engineering change orders.
• Oversight the engineering area for external and internal audits assuring the compliance QMS vs International Standards included but not limited to ISO:13485 for compliance with customer requirements or legality for the manufacture of medical devices.

EDUCATION

• High school diploma.
• Technical Certificate in a STEM area or University engineering student.

KNOWLEDGE AND SKILLS

• High level of knowledge on validations
• Proficient in using CAQ and SAP
• Written and Spoken English - intermediate/advance
• Knowledge of good documentation practices
• Knowledge of ISO 13485

EXPERIENCE

• 1-3 years of experience in medical industry