About this role
Nolato MediTech develops and manufactures polymer products and systems in close cooperation with leading customers within medical technology and pharmaceuticals. We are a world leader in injection molding of silicone and have extensive knowledge in injection molding thermoplastic medical technology products, with special competence in 2K and 3K molding. Medical Excellence is our way of exceeding our clients very high standards and expectations. By adapting the principles within Lean to good manufacturing and documentation practices (GMP & GDP), we are increasing value for our clients. Nolato MediTech is expanding and looking for an experienced Quality Engineer to our quality department. ROLE RESPONSIBILITIES As a quality engineer, you will be responsible for planning and executing the validation activities. The validation work is carried out mainly on injection molding tools/processes and on assembly equipment where your main responsibilities are to plan, document and lead validations and qualifications in conformance to current regulations. Furthermore you will: • Lead and conduct risk analysis (p-FMEA) to develop various validation tests • Issue validation plans, protocols and reports • Lead qualification tests • Conduct deviation investigations • Lead improvements projects • Provide statistical calculations and analyzing using software Minitab As a quality engineer, you have a continuous and close contact with project managers, technical engineers and the purchasing department. BACKGROUND AND PROFILE We believe you to have a bachelor degree or similar level in experience and worked as a validation engineer in the pharmaceutical and / or medical device industry for at least 3 years. You should have good knowledge of: • GMP/ ISO13485 • Report writing (IQ, OQ, PQ) • Production and manufacturing processes • Statistical planning, analyzing and evaluation of data As a person, you should be quality minded, driven, proactive, structured and analytical. You will work in a customer-oriented, international environment so you must be fluent in both English and Swedish. The position is a permanent full time employment and placed in Hörby. INFORMATION AND APPLICATION You apply by sending your CV and cover letter to [email protected] For information about the position, please contact Arléne Dahl, Quality Director, [email protected] , 0768-880007. Please apply no later than 2018-08-03.