Job title: Quality Assurance Specialist
Location: Western Business Park, Shannon, Co. Clare
Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept.
Summary:
The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing including secondary packaging activities and Distribution.
Responsibilities:
* Aid the team in the development implementation and maintenance of the Quality Management System.
* Support the operation of the Quality Management System & Documentation control such as:
o Change Controls, CAPAs and Non conformances, Training, Internal, vendor and third party audits, participate in product and process risk assessments.
o Perform Internal Audits or Supplier audits.
o Perform Supplier Qualification & monitoring as requested.
o Drive continuous improvement initiatives within the QMS.
o Partake in Customer specific or internal quality projects.
o Perform QA Verification of activities performed in production.
o Review and update Quality System documentation (procedures, Reports) as requested.
o Partake in activities for design & process validation.
o Take part in Notified Body Audits and Audit preparation as requested. Generate Quality Metric reports as required and assist in any other data compilation as requested.
Job title: Quality Assurance Specialist
Location: Western Business Park, Shannon, Co. Clare
Benefits: Good salary, Healthcare, pension, 25 days holidays, opportunity to grow your career with exciting Medical Device company working on projects from concept.
Summary:
The Quality Systems specialist role will involve supporting the development and implementation of the Quality Management System with my Medical Device client in order to maintain 2017/745(MDR), ISO 13485, ISO 14971, ISO 9001 and FDA QSR standards and requirements. The QMS includes medical device design and Development, Manufacturing including secondary packaging activities and Distribution.
Responsibilities:
* Aid the team in the development implementation and maintenance of the Quality Management System.
* Support the operation of the Quality Management System & Documentation control such as:
o Change Controls, CAPAs and Non conformances, Training, Internal, vendor and third party audits, participate in product and process risk assessments.
o Perform Internal Audits or Supplier audits.
o Perform Supplier Qualification & monitoring as requested.
o Drive continuous improvement initiatives within the QMS.
o Partake in Customer specific or internal quality projects.
o Perform QA Verification of activities performed in production.
o Review and update Quality System documentation (procedures, Reports) as requested.
o Partake in activities for design & process validation.
o Take part in Notified Body Audits and Audit preparation as requested. Generate Quality Metric reports as required and assist in any other data compilation as requested.
Requirements:
* Qualifications: Third level qualification in natural sciences (Certificate, Diploma, Degree level).
* 3+ years’ experience in Quality and Good Documentation Practices in a highly regulated industry (pharma, medical devices).
* Good planning and organizational skills.
* Good communication (oral and written).
* Hardworking and highly motivating individual, with good attention to detail.
Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie
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