Job Description:
We are seeking a highly skilled Senior Quality Systems Engineer to join our team. In this role, you will play a key part in implementing and maintaining our company's Quality Management System.
About the Role:
1. You will be responsible for ensuring that our Veryan Quality Systems comply with all relevant regulatory requirements, including Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485 and Japanese Ministerial Ordinance #169.
2. Maintenance of quality management systems and continuous improvement thereof is also within your scope of work.
3. You will act as Coordinator for CAPA (Corrective Action Preventative Action), Complaints & Temporary Authorization processes to support owners in meeting required timelines.
4. You must review & approve Non-conformance reports which include investigation into root causes. Also obtain approval from colleagues on related tasks assigned by superiors where necessary before completing them.
maintain records properly relating these procedures so they remain traceable throughout production stages making sure accuracy prevails through accurate detail noted during each step done correctly first attempt avoiding unnecessary revisions thus reducing waste while promoting smooth operations!