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

• A third level qualification in an appropriate discipline is desirable.
• 2+ years’ Experience within a regulated GMP environment
• is desirable.

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. Cognitive Skills

• 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.

Ownership/Accountability

• Has a personal responsibility to commit to the AbbVie Vision, to engage and align with the AbbVie Strategic Imperatives, and to consistently execute in accordance with the AbbVie Operational Pillars and AbbVie 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.
• Every employee has a personal responsibility to commit to the AbbVie Vision, to engage and align with the AbbVie Strategic Imperatives, and to consistently execute in accordance with the AbbVie Operational Pillars and AbbVie Ways of Work.

Influence/Leadership

• May be required to support Cross functional teams and cost improvement projects.
• Complies with cGMP at all times.
• Considerable and continual care and attention to detail is needed to detect and avoid errors.
• Continual attention needed to ensure plant reaches its Quality objectives.
• Leads by example through compliant behaviour / actions.

Decision Making/Impact

• Works from the general instruction provided by management personnel in respect of the duties to be performed.
• Ensures any unusual observations or issues noted are reported to the Operations Quality Team Leader Supervision Received

• The incumbent has set targets and goals to achieve which are reviewed on a weekly/monthly basis.
• The incumbent receives only general instructions from management personnel as to manner to which duties should be performed.
• The incumbent is charged with responsibility for ensuring product compliance to specification and Quality System compliance.

Supervision Provided

• No direct reports.

EHS Responsibilities

• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

Our Vision:To be recognised as the best STEM Contracting & Permanent Recruitment company and
the Employer of Choice for top performing Recruiters.
For further information on this role please contact Hannah Doyle on 086 107 0950 - engineering@hero.ie Check out all our open jobs on our HERO Recruitment website –
https://www.hero.ie/

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