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Quality Operations Manager

Location: Galway
Reference no. : 1679
Date added: 29/07/2020
Salary: €Neg




Description

 

                           Quality Operations Manager

Reporting to the Quality Director, the Quality Operations Manager will be responsible for maintaining and driving continuous improvement of our clients Medicals product Quality and Compliance. The Quality Operations Manager will ensure a culture of continuous improvement is in place to drive improved compliance, effectiveness and efficiency.  
This position is responsible for ensuring full procedural compliance to the regulatory requirements of 21 CFR 820, ISO13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD)R sch3 and other applicable regulations. 

  

Job Responsibilities

-       Health and Safety - focus in line with plant objectives to ensure initiatives are successful and agreed targets are achieved. This includes accident reduction and 5S+1 program success. 

-       TEOA (TE Operating Advantage)  lead and support the program to achieve the star ratings through implementation of tools through the business, and drive performance improvements through the use of these tools. 

-       Works with the business unit and Engineering Manager to achieve the cascaded Plant objectives. 

-       Develop Quality Operations Strategy for the business unit.

-       Drive a Quality continuous improvement and innovation culture. 

-       Lead and support Cost of Poor Quality initiatives. 

-       Develop strong links with customer organisations. 

-       Ensure compliance to the Quality Management system in all activities. 

-       Participate in new product introductions to ensure quality is built into all products early in their life cycle.  

-       Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods). 

-    Management and continued development of Quality staff. 

 -    Promote awareness of the applicable regulatory requirements  and Quality Management system requirements throughout the organisation.   

-  Develop and implement Manufacturing procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum:

  • Delivery of raw materials and components
  • Manufactured devices and equipment
  • Documentation associated with these function                  

-       Develop, track, and report on the following administrative systems:

  • Department objectives
  • Personnel development and training

 

      - Support regulatory agency and customer Quality audits. Act on behalf of Plant Management during audits. 

     -  Ensure all aspects of the site QMS are managed and developed in line with regulatory standards, and ensure a culture of continuous improvement is in place to drive improved effectiveness and efficiency.   

     -  Authority to place products or processes on hold. 

     -  Design and develop forms and instructions for recording,                  evaluating, and reporting quality data. 

     -   Manage Corrective and Preventive Actions. 

     -  Drive the utilization of formal problem-solving techniques to resolve process-related issues. 

     -  As required, lead cross-functional teams to support resolution of product and/or process-related issues or objectives. 

     -  Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as FDA QSR (21 CFR 820), ISO 13485, RDC ANVISA 16/2013, MHLW MO 169, TG(MD) Sch3/ MDD, MDR Standards.

Qualifications 

-       Level 8 degree in Science, Engineering or related subject. 

-       5+ years relevant Supplier Quality / Quality Operations experience in GMP Manufacturing environment in Medical Device/Pharma industry.

 
Key Requirements 

-       Ability to work as a team member. 

-       Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role. 

-       Good organization and investigation skills are required. 

-       Excellent communication skills. 

 

For further information, please contact bernie on +353 93 41932 or e-mail your cv to bernie.dempsey@bdr.ie



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