Kvalitetsingenjör

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 65 employees including its own sales offices in France and the USA. For more information please go to www.plasmasurgical.com. Do you wish to join our exciting journey? Are you passionate about Quality work? Plasma Surgical is a fast growing company within the medical device industry. We are in the process of strengthen the quality organisation further and employ a Quality Associate with experience in medical device. The main responsibilities in this role will be - Serve as backup for Document Control Management - Serve as designate for Quality Manager in the final review and approval of DHR lot release records to ensure GDP and data correctness - Review documents for regulatory compliance - Prepare monthly Quality System reports as needed - Work with Engineering and Production to maintain, review or make changes to drawing specifications for components as needed including the assistance in creating/managing the Change Control process - Documentation - Supports incoming inspection when needed - Assist Production and Engineering in analyzing defects to determine origin - Communication with appropriate personnel as needed - Serve as back-up for label technician - Perform internal audits - Investigation of Returns, Complaints, Non-conformance and Production Issues - Train personnel in GMP Our candidate has a technical degree or equivalent experience with 3-5 years experience from the medical device and/or pharmaceutical industry. You have been working in a manufacturing company and have good knowledge of ISO 13485, FDA and QSR.. Problem solving, root cause analysis and development of quality systems are some of your specialties and you have previously done internal audits. Knowledge from Sex Sigma is a plus. Your English is on a high level written as well as spoken. We also want our candidate to have experience in statistical analysis, software and TrackWise (e.g CAPA, change control etc.)