Quality Tech -Med Device

PE Global (UK); Sligo; On-site; EUR 32,000 - 42,000; Full time

Job summary

PE Global are currently recruiting a Quality Technician for our Medical Device client site in Sligo on a 12-month initial contract. You will join the Quality Assurance team to support GMP-compliant operations.

The role focuses on daily quality system tasks, product testing, documentation control, and continuous improvements to ensure compliance with cGMP and ISO/FDA regulations. Attention to detail, consistency, and teamwork are essential as you will generate metrics for management review and

Qualifications

• Experience working in a GMP-regulated environment is desirable.
• Experience with quality systems and documentation control is desirable.
• Attention to detail and ability to adapt to new processes.

Responsibilities

• Work as part of the Quality Team to meet quality goals.
• Ensure actions comply with current GMP.
• Operate within QC/IQA and Metrology areas as required.
• Perform incoming product testing per approved specs.
• Perform in-process and final release testing per specs.
• Keep Management informed of Quality Events.
• Ensure quality system documents are complete and compliant.
• Audit the quality system with other personnel when required.
• Support Change Management including document review.
• Provide metrics for management review and monthly reports.
• Ensure training requirements are maintained.
• Participate in continuous improvement programs.
• Generate batch records as needed to support manufacturing orders.
• Complete disposition decisions for incoming materials.

Skills

Attention to detail

Regulated GMP experience

Quality mindset

Education

Third-level qualification

Job description

PE Global are currently recruiting for a Quality Technician for our Medical Device client site in Sligo on a 12-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

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

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.
• Complies with cGMP at all times.
• Considerable and continual care and attention to detail is needed to detect and avoid errors.