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Senior Quality Systems Specialist - Southern

Quality
Ref: 127 Date Posted: Tuesday 22 Aug 2017
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Senior Quality Systems Specialist - Plymouth

Our client based in Plymouth is recruiting a Senior Systems Quality Engineer to project lead and actively develop processes and procedures for the company QMS transition to ISO9001:2015, ISO13485:2016 and MDSAP (Medical Device Single Audit Programme).

Key functions:

Performs quality systems compliance activities in support of the company’s activities. Assures that quality systems procedures, processes, practices and controls are properly developed, implemented and maintained. 

Routinely provides guidance and leadership to engineers, document controllers and/or technicians for the duration of a task and project assignment.

Ensures the CAPA systems are operating effectively and close out of corrective actions meets expected deadlines.

Manages internal and external regulatory audits e.g. Notified Bodies, FDA, JPAL inspections etc.

Lead and manage cross functional project teams to resolve complex quality systems compliance projects, which may have significant impact on the business e.g. QMS certification, product registrations etc.

Work on multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion.

Principal Responsibilities

  • Clear and communicated project plan for QMS transition to ISO9001:2015, ISO13485:2016 and MDSAP.
  • Project actions and tasks completed on time.
  • Regulatory compliance, Delivery of objectives & Demonstrate improvement.
  • Review and approval of technical documents
  • Participate and lead problem solving teams
  • Project management.
  • Report on Key Project Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system
  • Produce written reports and make presentations.
  • Develop and write processes and procedures.

 

Other Duties

  •  Participate in Continuous Improvement activities
  • Will undertake any assignment or duty as required by business needs and Quality Compliance Manager.
  • Will undertake any assignment or duty as required by business needs.
  • Independently determine approach and assigned tasks
  • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
  • Liaise and communicate with other departments, customers, suppliers and other service providers.

Qualifications and Experience

Bachelors Degree, or equivalent, in an Engineering or Biological Sciences Discipline. 

Five years experience in a Quality Engineering role within a Medical Device, Sterile single use, Electro-Mechanical or Electronics Manufacturing environment.

Experience in a Medical Device facility and expert knowledge of ISO9001: 2015, ISO13485:2016, MDSAP and FDA Quality System Regulations (21 CFR 820).

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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