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Job Details

Quality Assurance Specialist / Quality Assurance / Quality / QA / Medical Devices / ISO 13485 / Medi

Company: X4 Group
Location: United Kingdom
Reference: JL1002
Closing Date: 10 Mar 17
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

Job Title: Medical Device Quality Assurance SpecialistSalary: £35,000 - £45,000Location: LondonAll applicants must have experience in both ISO 13485 & medical device regulations (MDD 93/42/EEC and amendments 2007).Job Description: The Medical Device Quality Assurance Specialist supports and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities. ...

Requirements:

Job Title: Medical Device Quality Assurance Specialist

Salary: £35,000 - £45,000

Location: London

All applicants must have experience in both ISO 13485 & medical device regulations (MDD 93/42/EEC and amendments 2007).

Job Description:

  • The Medical Device Quality Assurance Specialist supports and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities.
  • Reports to QA Manager / Management to create new Quality System procedures/instructions
  • Monitor and maintenance of existing processes
  • Assist in internal and external audit
  • Assist in creating and maintaining internal audit schedules and records including tracking CAPA activities as required
  • Assist in and prepare for the execution of Notified Body audits and track progress of responses
  • Assist in 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
  • Maintenance of technical files, OBL files and test reports of product conformity according to MDD 93/42/EEC and amendments 2007 (be aware of the latest regulation)
  • Assist with international product registrations

Key Skills:

  • Knowledge of quality systems (ISO 13485), associated documentation
  • Knowledge of medical device industry and medical device regulations (MDD 93/42/EEC and amendments 2007), including pertinent standards and guidances
  • Bachelor’s degree in a related field
  • At least 2-3 years’ experience working in a regulated environment
  • Be aware of the latest medical device regulation
  • Very proficient in attention to detail
  • Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment
  • Knowledge of Microsoft Office including Excel, with an ability to learn other computer based systems. 
  • Ability to work in collaborative and independent work situations
  • Ability to remain calm and receptive in fast paced situations

If this is something that either you or someone you know would be interested in, then apply online and call Jack on 0207 812 7700 to discuss your application further.

Key Skills: Quality Assurance Specialist / Quality Assurance / Quality / QA / Medical Devices / ISO 13485 / Medical Device Directive / MDD

Apply for this job: Quality Assurance Specialist / Quality Assurance / Quality / QA / Medical Devices / ISO 13485 / Medi

Contact Information:

Address:  Head Office
2nd Floor, Brettenham House
Lancaster Place,
London,
WC2E 7EN
England
Tel:  02078127700
Website:  Visit Our Web Site

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