Quality Technician

Sterling Engineering Ltd - Ireland & Europe; Sligo; On-site; EUR 32,000 - 42,000; Full time

Job summary

Sterling Engineering Ltd in Ireland seeks a Quality Technician for Medical Devices to join the Quality Assurance team. The role focuses on maintaining cGMP compliance, supporting QA activities, and ensuring quality events are managed effectively.

The incumbent will operate within QC/IQA and Metrology areas, conduct tests per specifications, and contribute to continuous improvement and documentation control across the site.

Qualifications

• A third level qualification in an appropriate discipline is desirable.
• 2+ years’ experience within a regulated GMP environment.
• Experience with day-to-day operation of a quality system in a regulated combination product/device manufacturing environment is desirable.

Responsibilities

• Join the Quality Team to ensure Quality goals and objectives are achieved.
• Ensure compliance with current good manufacturing practices (cGMP).
• Operate within QC/IQA and Metrology areas as required.
• Complete incoming product testing per approved specifications and procedures.
• Complete in-process and final release product testing per approved specifications and procedures.
• Inform management of all Quality Events or potential Quality Events.
• Maintain thorough, complete, and compliant Quality System documentation.
• Audit the quality system with other personnel as required.
• Support Change Management Process including product and Quality System document reviews and updates.
• Generate and provide metrics for management review, monthly reports and overall Quality Performance.
• Ensure training requirements are maintained.
• Participate in continuous improvement programs to enhance quality, safety, environmental and production systems.
• Generate batch records for manufacturing support as required.
• Complete disposition decisions for incoming material

Skills

Attention to detail

GMP compliance

Quality systems

Documentation

Education

Bachelor's degree or equivalent (relevant discipline)

Job description

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.

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.

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.