The Company

Our partner is active in the development of highly innovative life-changing products.

Responsibilities

Test method validations and process validations.
Release of products for clinical studies.
Review technical reports and design documentation.
Manage structural improvements in the QMS.
Introduce and implement the quality processes and tools required to ensure product quality.
Provide training for relevant QMS Management areas.
Manage and perform internal and external audits.

Requirements

Minimum Bachelor Degree in technical area or other relevant scientific field.
Minimum 5 years of industry experience.
At least 2 years of experience in medical device
Broad working knowledge of ISO 13485, ISO 14971, FDA QSR, EU MDD, EU MDR.
Experience with test method validations and process validations.
Experience in root cause analysis, corrective and preventive actions.
Experience with risk management.
Experience in writing and maintaining Quality Management System procedures,
and providing training on them.
Good knowledge of and experience with Quality Assurance & control methodologies.
Experience with internal and external audits.
Pragmatic approach to problem-solving.
Able to work per priorities and tight deadlines in a fast paced, time sensitive environment.
Good communication, reliable, independent, goal-oriented, pragmatic attitude.
Strong organization skills.
Fluent in English, reading and writing.
Experience with statistical software, e.g. Minitab is preferred.