Device Technician

To work as a team member in production/operations areas in line with all safety, regulatory and organizational requirements. Preparing equipment, work areas and materials and ensuring/verifying readiness of manufacturing operations

Responsibilities:

· Preparation and operation of moulding and ancillary equipment.

· Preparation and operation of automated assembly and ancillary equipment.

· Preparation and operation of Pad Printing and ancillary equipment.

· Preparation and operation of manual assembly and ancillary equipment.

· Troubleshooting day to day manufacturing issues which may impact on efficiencies, safety or quality.

· Completion of quality checks and achieving production quality targets.

· Supplying materials to the operations and equipment in a timely and safe manner.

· Responsible for labeling and packing of components and finished products.

· Operating of Coordinate measuring equipment, and other advanced metrology equipment.

· Operate fully automated and complex computer-controlled systems, including robotic and vision system technology.

· Participate in divisional project team for New Product Introduction and Improvement Projects.

· Resetting equipment as necessary to ensure the manufacture of quality components.

· Team coordination to maximize the effectiveness of all of the team members.

· Documentation of all activities in line with GMP requirements.

· Cross training within the team and training of new members.

· Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.

· Execution of routine manufacturing documentation, commissioning and validation protocols on an ongoing basis.

· Ensuring compliance with the Quality, Regulatory, GMP requirements and adherence to all AbbVie policies and relevant legislation.

· Ability to work on own initiative.

· Execute manual assembly and visual inspection as required.

Qualifications:

Essential Requirements

· Leaving Certificate or equivalent, desirable · or relevant work experience

· Working knowledge of: Microsoft Office Suite beneficial.

Desired Requirements

· 3rd level education.

Experience required:

Technical/Business Knowledge -Job Skills/Experience Required

· Minimum 1 year of experience in regulated manufacturing environment required.

Cognitive Skills

· The position requires a moderate level of manual work in the movement of raw materials and finished products. All personnel must be able to accomplish these manual tasks, while wearing appropriate PPE.

· The position requires a high level of attention to detail and mental concentration, to ensure total compliance with manufacturing operating procedures at all times.

· The position requires proven technical skills, to ensure the person can cope with technical demands of the position at all times.

· This position requires the total commitment to quality and safety at all times.

Ownership/Accountability

· 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.

· This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.

· Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.

· The position has a high level of autonomy, and individuals are expected to work on their own initiative.

· 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 tenacity to ensure closure of issues.

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Influence/Leadership

· May be required to support Cross functional teams and cost improvement projects.

· The Device Technician executes the majority of the manufacturing tasks.

· Serious manufacturing errors, if undetected, could ultimately lead to serious health implications for people using the finished products.

· Moulding and Assembly operations for Medical Devices require compliance with cGMP’s at all times. Failure to comply with cGMP’s could lead to failure to pass regulatory/quality audits which could potentially prevent the sale of products from the facility.

· Moulding and assembly operations for Medical Devices require the safe handling of chemicals. Failure to follow the safe work practices could lead to employee exposure to chemicals, resulting in serious health problems.

Decision Making/Impact

· Expected to handle all day-to-day queries, if major problem can refer to Operations Supervisor.

Supervision Received

The position will report directly to the shift supervisor who will ensure the goals are defined and resources available to each shift. The shift supervisor and Device Group Leader will provide the following services to the team members as required.

· Direct coaching/training of members as required.

· Clearly define individual goals.

· Ensure adequate resources are in place.

· Develop training plans for each individual.

· Monitor performance, and complete performance reviews with each individual.

· Develop a team culture with active participation from all members.

The Device Technician will organise the following elements of their workload:

· Cross training within the shift and direct training of new team members as required.

· Team management of participation in the continuous improvement activities.

· Self-auditing of shift activities, to ensure excellence of GMP/safety and manufacturing activities.

· Completion of all documentation and manufacturing control system transaction in line with all cGMP and operational requirements.

· Coordination between shift teams to ensure excellence in GMP/safety and manufacturing activities.

Supervision Provided

· No direct reports

· Maintains regular contact with support functions on site, i.e. warehouse, quality, technical support, maintenance, metrology and engineering.

· All of the manufacturing processes and instructions are confidential information.

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.