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 validationsProficient in using CAQ and SAPWritten and Spoken English - intermediate/advanceKnowledge of good documentation practicesKnowledge of ISO 13485EXPERIENCE
1-3 years of experience in medical industryReqID: 58192