Quality Technician

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.

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.