Quality Manager

Plasma Surgical is a leading-edge company in the medical device industry that develops and commercializes new proprietary tools for coagulation and cutting of tissues.The device generates neutral high energy plasma using argon gas.The result is a surgical method that is more favourable for the patient than existing technologies.The products are CE marked and approved by the FDA.Plasma Surgical has manufacturing and development in both Sweden and the UK.Overall, the company has over 25 employees including its own sales offices in France and the USA.Plasma Surgical is growing rapidly and now needs to further strengthen the QA/RA team with a local Quality Manager in Mölndal.The main task as a Quality Manager is to ensure that the company operates with an effective quality management system in compliance with all applicable Medical Device related laws and regulations in the European Union, USA and other associated territories.Further to this the Quality Manager will be responsible to maintain and promote awareness throughout the organization of the importance of meeting customer and regulatory requirements.The Quality Manager will also liaise with other sites to coordinate quality activities.Responsibilities: . Manufacturing support and in-process testing .Site documentation control . Maintaining quality records .Approval of documents for QA/RA content . Supplier control and development team member .Reporting data relating to quality objectives.. Participation in Risk Management activities .Process Validation team member . Participation in product validation activities . Conducting Internal Audits. .Report writing as appropriate.. New Product Development support For this new challenging position we are looking for a person with solid knowledge of the Medical Devices Directive 93/42/EEC, ISO 13485:2003 and the US Quality System Requirements.Experience from process validation, testing, risk management and document control is required as well as a thorough understanding of statistical techniques and application to manufacturing.The successful candidate should possess problem solving skills and ability to determine the root cause.Other key factors are excellent communication skills in order to demonstrate cross-boundary team-working and fluent in English written as well as spoken.Please apply at www.proffice.se/lifescience latest the July 26.