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Medical Devices Inspector, Inspections-Compliance

Employer
Thornshaw Recruitment
Location
Dublin (City), Leinster (IE)
Salary
Negotiable
Start date
4 Jun 2019
Closing date
4 Jul 2019

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Discipline
Quality, Auditor, GMP, Quality Validation Engineer
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

On behalf of our client, we are currently recruiting for a Medical Devices Inspector, Inspections, Compliance. This is a 3 year contract role.

Reporting to the Inspection Manager, the Medical Devices Inspector will be primarily responsible for: 

  • Plan and conduct proactive and reactive audits of manufacturers and other economic operators
  • Execution of audits relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities.
  • Execution of audits arising from the ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies 
  • Carrying out audits of custom made, Class I and other medical devices

KEY RESPONSIBILITIES

- Operational Objectives

o Prepare for, organise and carry out audits

 

o Write audit reports when acting as lead inspector and contribute to the preparation of reports for joint or accompanied audits

 

Assist in the compilation of data and preparation of management reports as required

 

o Apply risk management principles

 

o Submit reports as required and maintain appropriate records of meetings and activities

 

o Maintain a database of audits performed

 

o Assist in the development, implementation and maintenance of policy and practice guidelines and procedures. 

 

- Quality and Knowledge Management

Assist the managers of the Inspection section to ensure:

 

  • The effective implementation of the Quality Management System 
  • That there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained 
  • Performance Management
  • o Participate in the performance development programme (PDP) within the Inspections Section 
  • o Work with the manager to agree appropriate performance related targets o
  • Communication/Customer Focus
  • o Attend and contributing to meetings as required. 

QUALIFICATIONS AND EXPERIENCE

  • To be considered for his post, candidates must: 

o A degree in an engineering or other relevant scientific discipline

o Auditing experience in medical devices/technology or related healthcare industry with a good knowledge of the regulatory environment and relevant quality standards 

  • A minimum of two years' experience in the medical devices, pharmaceutical industry or notified bodies sector or relevant regulatory experience in the field of medical devices registration and/or vigilance
  • A full driving licence
  • Knowledge of relevant European and National legislation
  • A self-starter, capable of excellent communication, negotiation and decision making
  • Highly motivated and with the ability to manage deadlines
  • Excellent organisational and administrative skills o Demonstrable initiative and team working capabilities
  • - In addition, the following would be considered an advantage;

o A lead auditor qualification 

o Experience in the design, manufacture and/or quality assurance of medical devices

If you are interested in applying for this role please call Linda on +353 1 2784671 or email Ldunne@thornshaw.com Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. 

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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