QA/RA Manager

Location: London  |  Greater London  |  England
Sector: Life Sciences
Consultant: Life Sciences Team
Job Reference: HH/HQ1031
Salary: £50000 - £60000
Job Status: Permanent / Full Time

Job Title: QA / RA Manager

Location: London, NW

Role: Permanent

Hours: Monday – Friday

Salary: £50-60,000 +  Bonus

Start date: ASAP

Reporting to: Senior Management

My client are a Medical Device supplier and manufacturer, based in NW London. They have been running since early 2000s and have just aquired a new company to bring new avenues of business.

Overall responsibility :

  • To ensure that the Quality Management System (Medical Device) fully complies with the European regulation Directive 93/42/EEC and the latest version of the ISO 13485
  • Responsible for overseeing pharmaceutical projects carried by the Responsible person and the Quality Compliance Executive to ensure those comply with the GDP in accordance with regulation 18 of the Human Medicines Regulations 2012 (SI 2012/1916)

Day-to-Day requirements :

  • Maintain Quality Management System with respect to ISO 13485 & Directive 93/42/EEC
  • Gradual implementation of the future Medical Device Regulation 2017/745 and Food and Drug Administration 21 CFR Part 820
  • Propose a strategies to senior management and suggestions on possible changes regarding the EU regulation due to a possible brexit
  • Maintaining governing policies, standard operating procedures and work instructions. Address any gaps as discovered to the Senior Managers
  • Initiate corrective actions and actions to prevent the occurrence of any product non-conformities before and after delivery
  • Report on performance of the management system, including the need for improvement at the Management Review meeting
  • Work with cross-functional team to ensure that quality of product and services are achieved, improved and maintained in conjunction with functional audits and regulatory compliance
  • Work with cross-functional team in house and with critical suppliers to resolve product quality
  • Manage the supplier evaluation / audit and approval processes, maintenance of approved supplier list, monitor their on-going performance
  • Audit critical suppliers
  • Ensure awareness of essential regulatory requirements throughout the company
  • Provide accurate and timely reporting to senior management to assist planning and management of operations and communicate an appropriate compliance strategy
  • Post Production Monitoring and incoming goods inspection of approved devices or new devise samples
  • Review and contribute to contractual agreements and specifications with suppliers
  • Responsible for internal and external audits, reporting and liaising with notified body and competent authority
  • Responsible for the retention, maintenance and control of the Technical Files in accordance the applicable regulations
  • Liaise with suppliers to ensure their operations are fully compliant with the company`s policies such as Labour Standard Assurance System. Responsible for LSAS target level achievement, audited by third party
  • Contribute to business development by assisting in regulatory compliance of new products as such a revenue target is achieved
  • Verify label and labelling as per ISO 15223-1
  • Work on new product development, sample review and product evaluation
  • Work with external consultant to ensure the company is fully compliant with a range  of Regulations and ensuring that the company`s policies always reflect such updates
  • Keep accurate and up-to-date record as such the documents are legible, traceable and retainable
  • To ensure that new product development / projects / suppliers are properly planned, time well-organised and resources well-utilised
  • Other duties as assigned by Senior Management

If this is of interest, please click apply now or call Harvey in the Life Sciences team for more information.