Ogłoszenie numer: 173464, z dnia 2011-11-21
LINA MEDICAL POLSKA SP. Z O.O.
LiNA Medical is a Danish corporation that creates innovative medical device solutions within selected surgical specialties. Our mission is to develop, manufacture and market medical devices with the goal of improving the end users work conditions while securing a save and efficient treatment of each patient. Our philosophy is to offer problem solving products, which are convenient and easy to use. Our Specialists work closely with surgeons from all over the world with the purpose of developing customer orientated products.
LiNA has a full-time vacancy in the manufacturing unit in Sady n/Poznań available for:
QA/QC Specialist
Miejsce pracy: Sady
Opis stanowiska
- Change Request System;
- Document handling;
- Training of employees in new procedures and processes;
- Assistance with external audits;
- Lead auditor at internal audits as well as at supplier audits;
- Microbiological area; training, sterilization validation, tests etc.;
- REACH;
- Participation in the R&D project groups;
- Review of Risk analysis and Clinical Evaluations;
- Aging tests.
Wymagania
- Knowledge/education and training:
- Engineer, Pharmacist or other relevant Technical level;
- Quality Systems & standards knowledge (GMP, ISO, FDA)
- Experience/skills:
- Relevant experience (min 5 years) from the Medical Device, Pharmaceutical or Food industry;
- Familiar with ISO 9000, ISO 13485, MDD and FDA;
- Experience with different sterilisation methods is a must;
- Experience with bioburden and hygiene measurements required;
- Experience with manufacturing of Medical Devices is an advantage;
- Experience in auditing is an advantage;
- Fluent in English (reading, speaking, writing).
Competences required:
- Good communication skills;
- Efficient, accurate, work according to plan;
- Detailed oriented person;
- Flexible and hard working;
- High profile commitment to quality;
- Excellent computer skills;
- Positive and problem solving attitude;
- IT literate on a user level (Ms Office, MRP/ERP system);
- Must be willing to travel to Denmark frequently.