Aylesbury, England, United Kingdom
● Review and approval of Device History Records and QA release of new products. ● QA review and approval of service records, reworks and test reports. ● Working closely with service engineers on resolving issues and approving documentation. ● Supplier liaison regarding quality issues and outstanding actions. ● Handling Non-Conformances, CAPAs, Complaints, and Supplier Corrective Action Reports by raising, investigating and closing open records in the eQMS and engaging with subject matter experts from different levels of the company. ● Providing training on the use of the eQMS, device release process, and relevant procedures. ● Creating, updating, reviewing and releasing relevant SOPs, Work Instructions and Forms in the eQMS. ● Part of a cross-functional FMEA group for risk assessment ● Maintaining supplier approval records, and conductiong periodic re-evaluation of suppliers ● Conducting and supporting internal- and external audits ● Holding ISO13485 Lead Auditor certification
● Ensure compliance to ISO 13485 and GMP manufacturing ● In-depth knowledge of the company’s processes and medical device platforms (self-injection pens) ● Customer liaison for product quality ● Initiating and assisting the closure of Deviations, CAPAs, and Change Controls ● Conducting and assisting in Investigations and Root Cause Analyses, as well as participating in FMEA sessions as SME ● Completing regular Product Quality Reviews for non-medicinal devices and trending exception data ● Supporting customer visits and Business Review meetings ● Aid process improvement projects ● Support Customer and Notified Body audits, assist in the preparation of audit responses, track the resulting CAPA actions for timely completion ● Ensure compliance to the customers’ Quality Technical Agreements and product specifications ● Support complaint investigations
● Providing medical information responses to healthcare professionals and members of the public in line with the ABPI Code of Practice ● Keeping the product database up-to-date, reviewing new and existing entries for accuracy, sourcing and updating relevant documentation ● Reviewing TSE/BSE certificates to ensure compliance with the EU guideline EMA/410/01 ● Managing translation requests, and conducting internal quality checks ● Liaison with suppliers, manufacturers and other service providers ● Supporting internal departments, e.g. sales, quality, regulatory, procurement, tenders ● Recognising and reporting Adverse Events and Complaints, ● Providing monthly metrics and line listings to clients ● Reviewing documentation to assess suitable alternatives for products on supply problem ● Recognising and raising deviations and service complaints
● Handling Medical Information enquiries in English and Hungarian ● Liaison with clients ● Providing training on certain products, processes and enquiry handling ● Ensuring compliance with company SOPs, client specific processes, KPIs and deadlines ● Identifying and reporting Adverse Events and Complaints ● Performing quality checks on communication with clients and customers, logs, weekly reports, Adverse Event, Complaint, and follow-up reports ● Supporting new colleagues in a “buddy” system
Course: Advanced Methods and Techniques in Plant Biotechnology ● Gene expression analysis ● Laser microdissection ● Plant cell transformation ● Enzyme assay ● Protein expression analysis