Labelling Engineer II

HERO

Job Detail

Location Cork
Salary Negotiable
Posted
Role Type Contract
Contact Sinead Killalea
email Consulting@hero.ie

Labelling Engineer II

Apply Now

Job ID: JOB-13198
Title: Labelling Engineer II

Location: Cork

Duration: 12 month contract

Ensures the efficient operation of the Product Labelling function, working with internal and external stakeholders to ensure that all Product Labelling requirements are met in line with Global Labelling Standards and Procedures.

Responsibilities:

  • Responsible for the final review and co-ordination of labelling activities for all product labelling into the production environment.
  • Ensures effective planning and management of timelines for all aspects labelling and control of release into the production environment.
  • Decisive, self-motivated/capable of working on own initiative, and able to prioritize and a proactive approach.
  • Assist in review and Windchill change notice activities for the approval and release of other packaging components i.e. DFUs, Cartons, Pouches.
  • Monitor and ensure compliance with local and Corp policies and procedures.
  • Create, review and maintain curriculums associated with GLS (Global Labelling System) and associated processes.
  • Work independently to schedule and complete activities necessary to meet projects & production timelines.
  • Provide day to day GLS system support to all established Production lines and NPI (New Product Introduction) Projects.
  • Develop, maintain and enhance relationships with the clients global counterparts in Packaging/Labelling, Marketing, Regulatory and Quality functions.
  • Demonstrated ability to identify and work with cross functional organizations to implement label designs, packaging components and in the problem solving of labelling & packaging related issues as required.
  • Participate in global packaging and labelling projects, to ensure Cork is at the fore front and is involved in any testing/proposed changes on both existing and new products.
  • Familiarization with Medical Device labelling to 21 CFR 801 an advantage.
  • Establishes and supports a work environment of continuous improvement that supports the client’s Quality policy, Quality System & the appropriate regulations for the area.
  • Support relevant non-conforming event and corrective and preventive action (CAPA) monitoring progress where applicable and drive through to completion for all action items pertaining to label issues, including problem solving to resolution, root cause analysis and implementation of corrective item.
  • Communicate to teams and management on the progress of labelling related projects.
  • Represent the site as audit facing SME for Product Labelling and the associated Global & local processes & procedures.
  • Ensure audit readiness at all times and participate in Incident Review Board meetings on a quarterly basis.
  • Understanding of the clients packaging and labelling processes and how they fit into the overall product deliverables in line with the NPI process.
  • Knowledge of Change Control Systems, Bill of Materials, Preventive & Corrective Action systems, Labelling Management systems etc. Knowledge of Windchill, MES, SAP, eCapa, Prisym applications an advantage.
  • Excellent written and verbal communication skills, with a high level of attention to detail.
  • Strong command of MS Office – Word, Excel, Visio, PowerPoint.
  • Knowledge of EU MDR requirements is an advantage.
  • Experience in the medical device industry is an advantage.

Quality System Requirements:

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the clients Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Management Requirements

Not applicable.

Job Scope and Levelling Guidelines:

Knowledge:

An experienced professional with a complete understanding and wide application of principle, theories, and concepts applicable to a labelling system. Applies a full understanding of area of specialization to resolve a wide range of issues. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships.

Planning and Organization:

Plans, organizes, and prioritizes own daily work routine to meet established schedule. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

Problem Solving:

Develops solutions to a variety of problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

Discretion/Latitude; Supervision Received; Decision Making:

Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.  Interprets, executes and recommends modifications to local and company policies.

Consequence of Errors:

If errors on final label design, or packaging component are printed/used in the production environment, escape the clients controls and into distribution to customers, there is a high possibility of a recall.

Business Relationships and Project Management:

Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.

Operations Involvement/Direct Work Involvement:

Investigates and solves problems that impact work processes and personnel within a unit or department.

Project Involvement:

May participate in various department project teams.

Impact:

Ensures that projects are completed on time following established procedures and schedules.  Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources.

Influence and Leadership:

Promotes department goals by selecting, motivating, and training capable staff. Leads the activities of assigned staff by communicating and providing guidance towards achieving department objectives.

Mentoring:

Participates in the development of less experienced staff in labelling department or external department by setting an example, providing guidance, and offering counsel.

For further information on this role in Cork please contact Sinead Killalea on consulting@hero.ie  or 086-1287246

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

 

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

 

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Sinead Killalea

JOB-13198

Apply Now

Labelling Engineer II

Sinead Killalea

Role Type Contract
Contact Sinead Killalea
email Consulting@hero.ie
mobile +086 1287246
linkedIn profile click here

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