Ogłoszenie numer: 173463, z dnia 2011-10-31
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 Manager Poland
Miejsce pracy: Sady
Opis stanowiska
- Ensure QA-PL is in compliance with the overall strategy of Lina-Medical as well as authorities and customers requirements;
- QA-PL strategy and execution;
- Building the awareness of Quality across the company through development of quality standard requirements, as well as promote the quality awareness among the employees;
- Foster excellent relations with internal and external customers to ensure continuous release of products, meeting the desired Quality;
- Ensure that the quality policy is communicated and understood within the facility in Poland;
- Determine facility quality objectives together with the QA/RA Manager to achieve company goals and targets;
- Ensure that processes needed for the facility are established, implemented, maintained and improved;
- Review the facility quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness;
- Represent the Polish site in quality matters;
- Coordinate internal and external audits / inspections related to Polish facility;
- Perform internal audits and supplier audits;
- Coordinate and implement corrective and preventive actions;
- Ensure products, projects and programs are in compliance with the requirements of internal & external procedures and regulations;
- Coach, train, manage and develop the quality assurance department in Poland / employees.
- Participate at staff meetings;
- Work out annual business plan for the QA-PL dept;
- Secure close cooperation with QA-DK dept;
- Review Manufacturing and Quality documents to facilitate final release of medical devices to market;
- Monitor the production environment and secure environmental monitoring is conducted according to schedule;
- Head of Quality Control and Complaint handling projects;
- Authority given for final release of sterilization process to LiNA Medical products treatment;
- QA approvals and dispensations within LiNA Medical Poland;
- Tests and sampling related to products manufactured in Polish facility;
Wymagania
- Knowledge/education and training:
- Production/quality engineer or PhD in a quality management area;
- Experience/skills:
- Production/quality engineer and/or PhD in quality management area;
- Experience from similar position of management within Medical Devices or Pharmaceutical industry;
- Experience in auditing;
- Familiar with ISO 9000, ISO 13485;
- GMP, ISO, FDA, MDD;
- Fluent in English – verbal and written;
- IT on a user level.
Competences required:
- Fine organisational skills, open minded;
- Excellent communication skills at all levels;
- Efficient, accurate, work according to plan;
- Flexible, pro-active & hard working;
- Team Player;
- Positive, supportive & problem solving attitude;
- People manager / coach;
- High profile commitment to quality;
- Personal learning and development attitude.