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Quality Manager (Galway)

Repromed ireland

Dundrum, Ireland


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Role: Quality Manager Galway

 

Purpose of the Role: To be responsible for the co-ordination and development of a quality and safety system and provide leadership and advice to the organisation within the scope of Quality and Regulation.

  • Ensuring that the specific requirements of the Quality System are established, implemented and maintained.
  • Regularly reporting and communicating the performance of the quality system to management.
  • Driving and implementing key changes, continuous improvement and best practice in Quality systems and procedures across the company.
  • Promoting awareness of customer requirements throughout the company.

 

Staff Type: Quality

Reporting To: Chief Operations Officer

 

Key Job Responsibilities:

  • To carry out all activities, and areas of responsibilities, in line with the Quality & Safety Management System
  • Manage the corrective actions and provide an independent authority in the event of internal disagreement
  • Manage the Change Control processes
  • Manage the internal and external audit processes, ensuring adherence to all appropriate internal and external regulatory requirements.
  • Prepare and analyse Quality reports and metrics regularly (weekly/monthly) e.g. KPIs, Quality Report etc - coordinating resulting process improvements with management.
  • Prepare and maintain documentation in compliance with the appropriate regulatory requirements.
  • Manage and close-out any patient complaints that were escalated from line managers. Implement learnings and preventative actions as a result.
  • Be a key driver of Quality best practice with the company, working closely with all staff to develop and enhance the Quality systems through training, involvement, delegation and regular review.
  • Any other reasonable duties as may arise from time to time to be expected with the job.

 

Specific Duties:

Quality and Safety:

  • Quality System – oversight of all aspects of the Quality and Safety System such that activities are co-ordinated to maximise impact.  This includes all quality development as well as clinical and non-clinical risk management. 
  • Statutory requirements – incorporation of all statutory requirements as part of the Quality and Safety System including governance requirements, health and safety legislation and patient care requirements.
  • Provision of Staff information and Education – ensuring staff are updated on all activities and developments in relation to the creation and ongoing management of the Quality Management System.
  • Policies and Procedures – assist in development and implementation of the company’s policies and procedures, in conjunction with all staff, including codes of practice, strategies, work instructions and documentation.
  • Development of Quality Evaluation Mechanisms – including clinical audit, performance, measurement and patient / staff feedback.
  • External Review – facilitate, develop and support the implementation of bench marking, together with other appropriate review and monitoring methodologies to enable staff assess the effectiveness of care and service delivery, this may include internal audits, inspections and peer review.
  • Communication – elicit and stimulate information, feedback and ideas from staff and act as a conduit to the Management Committee in the optimisation of the quality and safety awareness process.
  •  

Inspection:

  • Reporting – provide updates to Management on all activities relating to the inspections, implementation and follow up process.
  • Provision of Staff Information and Education – ensuring staff are updated on all issues relating to the process.
  • Documentation – organise all documentation required as part of the validation process
  • On-Site Inspection – coordinate and lead any on-site inspections by HPRA, CHKS or any other relevant body
  • Follow-up & close out – assure appropriate follow up is accomplished including aspects of continuous assessment including reports and revisits.
Experience Required:  Qualifications and Experience: Essential: BSc in Quality Management / Quality Engineering Experience in managing a QMS to meet ISO / JCI / CHKS standards Experience in validation activities Experience in dealing with regulatory authorities, i.e. HPRA, FDA etc. Excellent organisational and communication skills Understanding of GDPR 2018 an advantage Previous healthcare/life science experience an advantage
Education Required:  Qualifications and Experience: Essential: BSc in Quality Management / Quality Engineering Experience in managing a QMS to meet ISO / JCI / CHKS standards Experience in validation activities Experience in dealing with regulatory authorities, i.e. HPRA, FDA etc. Excellent organisational and communication skills Understanding of GDPR 2018 an advantage Previous healthcare/life science experience an advantage
Salary:  available on request
Closing Date:  Once position is filled





Contact: Shane Nugent
Repromed ireland
ReproMed, Rockfield Medical Campus, Northblock
Dundrum, Dublin, Ireland
D16
Phone: 834353127
Informal Enquiries:
Website: http://repromed.ie
Applications: Online Submission Link

Date Added: 25 March 2020    



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