QUALITY ASSURANCE ENGINEER

Job Descriptions

Join our dynamic team in Quality Assurance Engineer, where precision meets innovation in the medical sector. As a Quality Assurance Engineer, you'll play a pivotal role in ensuring the excellence of bespoke parts vital to medical advancements. Embrace the opportunity to contribute your expertise to our cutting-edge projects and make a tangible impact on healthcare worldwide.

Salary and Benefits:

• £25,000 - £30,000
• Perks at work – discounts with high street and online retailers.
• Standard pension
• Parking on site

Quality Engineer Responsibilities:

• Completing post-market surveillance reports. Including Periodic Safety Update Reports (PSURs) and Safety and Clinical Performance (SSCPs)
• Manage clinical data for – Direct feedback from client / Customer complaints / Patient Reported Outcome Measures (PROMs) / Vigilance database / Published clinical literature
• Assist in Clinical Research Organisations (CROs) during clinical investigations.
• Input into Clinical Evaluation Reports (CERs)
• Report to clinical authorities.
• Assist in managing QMS by: providing input for customer complaints / Input preventative and corrective actions / Conduct internal audits / Maintain SOPs and other QMS documents. 

Quality Engineer Skills Required:

• Ability to work with external partners (surgeons)
• Able to communicate with other departments when needed.
• Knowledge of ISO 13485, 21 CFR Part 820 and the medical device regulations (desired)
• Create regulatory documentations
• Assist in maintaining QMS.
• During external audits, provide appropriate inputs. 

Quality Assurance Engineer role is Commutable from: Bath / Potishead / Keynsham / Nailsea / Yate / Thornbury / Clevedon