Capa Engineer

**About Convatec**About ConvatecAbout the role:The trending and analysis of data related to product/process non-conformance that may occur during the manufacturing process or due to customer complaints, including but not limited to sample evaluations (where applicable), trend analysis, impact assessment, full reporting of investigations, and follow-up on any pending actions due to the results of investigations.Maintains the CAPA and Non-Conformities system, using the corporate electronic system according to ConvaTec's Global processes and standards and regulations of Quality Systems for medical devices.**Responsibilities**:Generate reports from the electronic system to identify reported NC/CAPA’s reported.Carry out the periodic evaluation of non-conformity and CAPA files to ensure that they are complied with within the established time and complying with quality standards.Conduct a preliminary investigation of the root cause and be part of the team that generates action plans to attack the identified causes.Guide and coaching NC/CAPA Owners on the execution and creation of the Root Cause Analysis formReview and approve research related to quality system improvements.Investigate assigned cases within established deadlines, including sample evaluations, documentation review, staff interviews, trend analysis, etc.Assist in the electronic updating of non-conformities and CAPA.Coordinate research support with the affected areas.To offer training, advice, and support to users of the system.Execute reports and trend analysis related to distribution center non-conformities, IS non-conformities and CAPAs according to needs monthly and distribute them and notify their supervisor of any adverse report to take immediate action. Participate in or lead NC/CAPA follow-up meetings.Run monthly reports and trend analysis related to distribution centers and non-conformities according to needs and distribute them.Participate in forums related to NC/CAPA/SS/HHECalculate, evaluate, and guarantee the result of the indicators of the quality management system.Provide support in the preparation together with his/her supervisor and the other functional areas of Quality of the presentations of weekly and monthly indicator meetings and the semi-annual management review.Acting as Quality Approver for NC/CAPAAny other responsibilities assigned by your supervisor.Skills and Experience:Bachelor’s degree (industrial area or similar)1 year of experience in a similar position in medical devices.1 year handling of systems experiences (NC’s, CAPA, etc).Verbal and written English required.Strong computer skills, including Excel, PowerPoint, and WordAbility to work with electronic databases.Knowledge of root cause analysis tools requiredFamiliar/Knowledge on MDSAP (FDA QSR's, J-PAL/Ordinance No.169, ANVISA, AUS, CANADA), required.Familiar/Knowledge on GMP's and ISO 13485, or similar regulations required. Familiar/Knowledge of EU Medical Device Directive 93/42/ECC, EU Medical Device Regulation (2017/745).Teamwork and integrity.Proactive and disciplined; Focused on results.Knowledge of data analysis.Drafting skills and regulatory documentation.Strategic thinking.**What you’ll**g**et**:- Competitive salary + bonus- Training & development- Collaborative, supportive culture**Ready to join us?**LI-ML1**Beware of scams online or from individuals claiming to represent Convatec****Equal opportunities**Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.**Notice to Agency and Search Firm Representatives****Already a Convatec employee?