DaklaPack is a company that is constantly growing and developing. To meet the highest quality control standards and certification requirements, we are looking for a Quality Assurance Manager.

If you are not afraid of a challenge and can guarantee the strict quality control requirements that we must meet, then we are looking for you!

TO DO LIST

• Implement, manage, maintain and improve a Quality Management System
• Conduct Management Reviews and CAPA meetings
• Person Responsible for Regulatory Compliance (PRRC) towards, amongst others, In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and Medical Devices Regulation (EU) 2017/745.
• End responsible for QA/QC activities like Final release of products, inspections and Training
• Support multi-site new product development projects and launch of new products. Responsible for realizing and ensuring design and development activities, including Design control, Risk Management, Process validation, EU Declaration of Conformity (DOC) and Technical Documentation.
• Identify and interpret new or revised regulatory requirements for Medical Devices
• Coordinate and manage audits and regulatory activities with respective agencies
• Conformity of the device to the manufacturer’s prior to release

EXPERIENCE & KNOWLEDGE

• At least five years’ Medical Devices experience within QA
• A diploma, certificate, or other evidence of formal qualification from a university recognized as equivalent by the concerned Member State in law, medicine, pharmacy, engineering, or another relevant scientific discipline, with at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
• Manufacturers of custom-made devices are to have at least two years of professional experience within a relevant field of manufacturing
• Experience to work in a multi-cultural work environment
• Excellent communication in Dutch and English (Spoken and written)
• Optimistic, Solution minded, Decision maker and Strong communicator

HOW?

• You work closely with colleagues from various departments in an enthusiastic international team
• You are stress resistant and you know how to keep an overview of your work all times
• You are creative and have an excellent eye for detail
• You are available 40 hours a week (is not a must)

WE OFFER

• A challenging job as a Quality Assurance Manager at one of the market leaders in innovative  (medical)  packaging solutions
• A modern environment where passion and good atmosphere is key to be successful
• Good benefits and a market-based salary
• An attractive bonus option
• Good career and growth opportunities
• Possibility to follow courses

Are you the professional who can strengthen our organization? Then apply directly!