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Quality Technician
Industry specialist
Tommy McKeown
Senior Recruiter
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Contract
QUALITY TECHNICIAN MEDICAL DEVICES
Job Dept: Quality Assurance
Responsibilities
Essential Requirements
Experience Required
Technical/Business Knowledge -Job Skills/Experience Required
Cognitive Skills
Influence/Leadership
Decision Making/Impact
Supervision Received
Supervision Provided
EHS Responsibilities
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.