Labelling and Specifications Technician

Location: Coleraine

Contract Type: Permanent Full Time

Closing Date: 18 June 2021

Salary: Competitive

Labelling and Specifications Technician

ABOUT THE ROLE

To work alongside relevant departments including Quality, Regulatory, Engineering and Marketing to develop and maintain artwork and documentation relating to medical device labelling, usage instructions, artwork and device specifications. 

 

KEY ACTIVITIES

  • Working alongside relevant stakeholders to develop and maintain artwork and documentation for medical device labelling, instructions for use (IFUs) and device specifications.
  • Maintenance of device technical files (TFs) within a PDM system.
  • Maintenance of CAD models within a PDM system.
  • Processing Engineering Change requests in relation to TFs, Bills of Materials, label and IFU artwork.
  • Working as part of a team to support site manufacturing areas with engineering solutions for device labelling and packaging and device documentation specifications.

Product and process development

  • Liaise with relevant departments to input to solutions to resolve problems that arise in production.
  • Development of barcoding, QR and GTIN solutions for product IFU and labelling.
  • Participate with colleagues in technical writing for IFU and label artwork.
  • Follow QMS and non-QMS SOPs for workflow in relation medical device labelling artwork and device specifications documentation.
  • Follow QMS and non-QMS SOPs for maintenance of files, directories and libraries relating to QMS records, TFs, CAD models, IFUs and labelling.
  • Assist the relevant teams in the development of packaging and including technical input into marketing materials.

Quality System

  • Maintain files in accordance with relevant QMS procedures and make them available for review during Quality Audits.
  • Carry out technical investigations and support information, as required for the closure of customer complaints by the Quality Manager and others.
  • Responsible for adopting and maintaining safe practices in the development of product processes.

Health & Safety

  • Following all Health & Safety guidelines within the Department and notifying the Company of any incident, accident or near miss.
  • Wearing Personal Protective Equipment as required for the task being carried out

Other

  • To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
  • To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
  • To adhere to the company’s Quality policy and Environmental policy
  • To undertake other duties as may be reasonably required

 

KEY SKILLS

Essential

  • 4 GSCEs A* to C
  • Strong command of written English
  • Strong and demonstrable 2D design skills
  • Good verbal communication skills
  • Competent in the use of Microsoft office packages

Desirable

  • A degree or third level qualification in a graphic design, multi-media or engineering discipline.
  • Competency in In-Design (or similar) graphic design software
  • Experience in a regulated quality or engineering environment
  • Experience of Technical Writing in a product manufacturing environment
  • Experience in label design for manufactured products
  • Strong report-writing skills
  • Previous experience in a similar role

 

KEY WORKING RELATIONSHIPS

  • Group Marketing
  • Site Quality Management Team
  • Site Production Managers and Supervisors
  • Site Regulatory Affairs Team
  • Site Marketing

External

  • Label and printing service suppliers
  • Notified bodies during external audits

 

ADDITIONAL INFORMATION

  • Ability/willingness to develop within the role
  • Ability/willingness to attend training courses in relation to the role and the needs of the department
  • Ability/willingness to travel to other Eakin Group sites as required

 

COMPETENCIES

Problem solving – Generates and promotes solutions.  Sees clearly which is the best way forward.  Able to make decisions and commitments within appropriate time frame.

Resilience – Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and doesn’t dwell on past events.

Team Working – Enjoys participating in group activities and likes to work in close proximity with other people.  Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.

Following Directions – Is motivated to accept and comply with standards and instructions and has a strong conscience about delivering what is promised or expected.  Doesn’t like letting people down and works productively in cooperation with, and support of others.

Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments.  Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail

Information Gathering – Enjoys dealing with and refers to factual data.  Likes to be well informed and drills down into details.  Prefers to access wide range of information and opinion before making decisions and when solving problems.

Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account.  Likes to monitor to ensure that things are implemented and delivered effectively

Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’.  Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.

Oral Communication – Talks readily and confidently to people, expressing themselves with obvious ease.  Speak out and makes themselves heard, often playing a leading and influential role in debate and discussion.

Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships.  Doesn’t give up easily in the face of opinions that differ from their own.  Influences others to reach conclusions and gain agreements.

Technical expert –full breadth of technical knowledge and can operate as a technical advisor, influencing others to achieve goals without relying on hierarchy. Keeps up to date on changes within their field and implements plans to ensure organisation is in a state of readiness.  Participates in industry and professional associations

 

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