Quality Tech – IQA – Sligo

Desired Skills: QA,Medical Device,Quality Tech

PE Global are currently recruiting Quality Tech – Incoming Quality Assurance for our client site in Sligo on a 6-month initial contract:

QUALITY TECHNICIAN MEDICAL DEVICES

Job Dept: Quality Assurance

Responsibilities

To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved.
Ensure that all actions comply with current good manufacturing practices.
Operate within the QC/ IQA and Metrology Areas, as required.
Complete incoming product testing per the relevant approved specifications and procedures.
Complete in-process and final release product testing per the relevant approved specifications and procedures.
Ensure Management is kept informed of all Quality Events or potential Quality Events Related to the product or process.
Ensure all Quality System documentation is thorough, complete, and compliant.
Audit the quality system with other personnel where required.
Support Change Management Process including Product and Quality System document review and updates.
Generate and Providing metrics for inclusion in the management review, monthly reports and overall Quality Performance
Ensure compliance with training requirements is maintained.
Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
Generate batch records for as required in support of manufacturing process orders.
Complete disposition decisions for incoming material

Essential Requirements

Experience Required

Technical/Business Knowledge -Job Skills/Experience Required

1 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment is desirable.
The position requires a high level of attention to detail and mental concentration, to ensure total compliance with operating procedures and Regulations at all times.
The position requires the ability to adapt to new processes on a regular basis.
The position requires total commitment to quality and safety at all times.
Has a personal responsibility to commit to the Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the Operational Pillars and Ways of Work
Requires good knowledge of Company Policies and Procedures and involves. working towards general results to achieve organizational needs.
Demonstrates an ethos of Right First Time at all times.
Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures, and guidelines.
Shows a high level of attention to detail and tenacity to ensure any issues noted are elevated to the Operations Quality Team Leader.
May be required to support Cross functional teams and cost improvement projects.
Complies with cGMP at all times.