Medical Device Labelling Coordinator

Requisition ID
2021-8787
# of Openings
1
Job Location(s)
Eight Mile Plains QL Australia
Position Type
Part Time
Expiry Date
16-4-2021
Category
Engineering

Overview

CookMedicalLogo

 

• Privately owned Global Medical Device Manufacturer
• Part time fixed term contract for 12 months
• Strong inclusive culture that values our people

 

 

We are looking for a hard-working, reliable and motivated individual to join our friendly, well respected and long-established company.


Fantastic opportunity to contribute your skills and experience to this part-time 12-month contract, working 16 hours per week, must be able to work Thursdays, other day is negotiable.


You will be joining our high-performing Post Market Engineering team where you can establish positive working relationships with internal and external stakeholders.


At Cook Medical, we are passionate about the work that we do in making a difference to patient lives around the globe. We treat everyone with respect and encourage our employees to be transparent, through open and honest communication and being appreciative of individual contribution.

 

Responsibilities

Key Responsibilities:

 

• Create design change checklists to document change management plans.
• Confirm labelling complies with the labelling sections of general safety and performance requirement (GSPR) checklists.
• Review and approve new or updated printed product materials in product lifecycle management (PLM)_system.
• Assist with interfacing design history files (DHFs) with other labelling systems.
• Support implementation of universal device identifier (UDI) labeling.
• Support implementation of new IFUs.
• Communicate with product managers to confirm European markets required for translation purposes.
• Create and develop material specifications for all printed product materials.
• Monitor and report project progress to key stakeholders.

Qualifications

Key Requirements:  

 

• Demonstrated competency in interpretation of technical specifications (quality inspector, production worker) essential
• Experience working in a highly regulated environment in accordance with Standard Operating Procedures preferred
• Experience or familiarity with Good Documentation Practice preferred
• Intermediate Microsoft Office proficiency (Word, Excel, Powerpoint) essential
• Training or experience with Product Lifecycle Management systems desirable
• Highly organized with a focus on attention to detail
• Communicates clearly and concisely, in a manner appropriate to the intended audience
• Effectively presents ideas, information, and materials to individuals and/or groups
• Good written and verbal communication and interpersonal skills
• Able to learn and properly apply new job-related information in a timely manner

 

Cook Can Offer:

 

• Stability of a long-established company
• Values recognition and service awards
• Subsidised cafeteria
• Flexible start/finish times
• Ongoing training and development
• Strong inclusive culture that values our people

 

Candidates applying to this role must be a permanent resident or citizen of Australia. 
This part-time role is to commence as soon as possible and shortlisting will commence immediately. 

 

About Cook Medical:

 

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. Headquartered in the United States, we also have manufacturing locations in Denmark, Ireland and Australia. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.


As a global, modern company we ensure that our company values reflect our everyday business practices, staying true to what Bill and Gayle Cook started in 1963.  At Cook Medical, we embrace diversity and inclusion. We understand that everyone can offer a unique perspective and can contribute their own ideas to improve how we work. We strive to create an environment where our employees can feel empowered to make decisions and can bring their full, authentic selves to the workplace.


We are seeking conscientious employees who align with our values, and we encourage people of all genders, races, ages and abilities to apply for roles within our organisation.

 

For more information please visit www.cookmedical.com.au/careers
The future of medical care has never been more exciting.

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