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QA/RA Manager Medical Devices

Vacancy Title: QA/RA Manager Medical Devices
Contract Type: Permanent
Location: Skipton, North Yorkshire
Industry:
Salary: £45000 - £50000 per annum
REF: J906395_1602169680
Contact Name: Tom Hammond
Contact Email: tom.hammond@russell-taylor.co.uk
Vacancy Published: 16 days ago

Vacancy Description

QA/RA Manager Medical Devices

Location: Skipton

Type: Permanent

Salary: £45,000 - £50,000

Additional Benefits: 5% pension contribution, 25 days hol with 1 day increase per year up to 30 days plus bank hols, Private health insurance and cash back scheme.

Hours: 9am - 5pm Monday - Friday

Our client is an established innovative manufacturer of medical devices and is looking to bring in an experienced manager. With huge plans for the next 6 years and new products being developed; the successful candidate will have a team built around them and given the autonomy to strive.

Key Responsibilities

  • Manages and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
  • Accountable for all Quality and regulatory requirements for the business
  • Accountability for monitoring and maintenance of existing processes
  • Accountable for internal and external audits
  • Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
  • Accountable for the execution of Notified Body audits and track progress of responses
  • Accountable for investigating quality issues and interact with products suppliers regarding these
  • Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures
  • Ensure that the quality system is understood and applied throughout the organisation on all levels by personnel concerned
  • Authorising product release to stock and completion of relevant records upon receipt
  • Accountable for the maintenance and generation of technical files, test reports of product conformity according to MDD and MDR.
  • Leads and co-ordinates regulatory activities to support assigned projects.
  • Ensures effective co-ordination and implementation of regulatory activities in support of product development, registration, lifecycle management and maintenance in the region.
  • Ensures effective planning and tracking of activities.
  • Ensures effective co-ordination of the review and approval of product-related packaging as required, to ensure regulatory compliance.
  • Ensures that budgets and forecasts are developed and actuals managed in line with corporate requirements.
  • Clearly defines and communicates regulatory strategy in support of new product registration, in line with commercial objectives.
  • Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development, registration, lifecycle management and maintenance.
  • Develops proposals for initiatives and implements, as required.



The Person:

You will already have experience in both ISO 13485 and medical device regulations (MDD and MDR) as well as:

  • Proficiency in quality systems (ISO 13485), associated documentation
  • Proficient medical device industry and medical device regulations ((MDD and MDR)
  • Bachelor's degree in a related field
  • Minimum 5 years' experience working in Quality and Regulatory roles within Medical devices.


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