Technical support to the manufacturing of Medical Devices – surgical instruments
Support implementation and maintenance of Quality Control system
Close dialog with our Danish R&D, QA and Manufacturing Engineering team
Technical investigation of complaints (consumables and capital equipment)
Process validation
The Challenge
As Manufacturing Engineer you will join a successful team working with manufacturing issues within a specific product portfolio, such as:
Rationalization / improve efficiency and quality of manufacturing processes
Implementation of new or upgraded products in manufacturing
Support our complaint handling process
You will be reporting to the Plant Manager (in Poland) and the Business Unit Manager (in Denmark) responsible for the product portfolio.
You will be responsible for:
Supporting the implementation of the Quality Control system – write instructions, determine in collaboration with other specialists what to control and implementation of the daily routines and follow up to secure a continuous flow.
Implement and document product and process changes in collaboration with the Business Unit.
Develop and implement manufacturing instructions for current and new products.
Investigation of customer complaints. The work will be done in close dialogue with our QA department and when needed, the R&D team in Denmark.
Planning and secure executing of process validation and systematic preventive maintenance of manufacturing equipment and technical installations (ventilation system for clean room, packaging equipment, soldering equipment etc.)
Ensuring continuous production process improvements (LEAN production and optimizing quality).
As secondary tasks, you will:
Implement or support other departments when changes are needed to products or process
The profile
Your have an education as engineer (manufacturing, mechanical or plastic) at Master Degree level. You have experience from the medical device industry or industry with similar requirements. You are familiar with the requirements from the Medical Device Directive and Standard in relation to GMP.
The position requires excellent skills in:
Executing task in accordance to agreed schedules
Create overview and prioritise tasks in accordance with overall activity plans
Documentation of activities in writing – English
Communicating across functions and borders
Creative in problem solving - find simple solution on complicated problems.
Keep focus on the important tasks in a from time to time very hectic atmosphere.
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