Back to Job Search

Senior Quality Assurance Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 19692

Our client a major multinational here in Galway are looking to hire a Senior Quality Assurance Specialist.


The Role:

In this role you will be responsible for implementation and maintenance of the quality management system as well as compliance of the affiliate and affiliate supplier/distributor network, working collaboratively with country managers to sustain and grow the business and provide guidance on Quality related topics. There will be several projects across multiple sites that will require coordination with other functional areas, and dependency on these other functional areas, to execute activities for the projects to be successful and timely. This job will require excellent communication skills, prompt and friendly follow up and the ability to motivate others within and outside of the Quality function. 

 

Purpose of the role:

  • Individual contributor with comprehensive knowledge in the specific area.
  • Ability to execute highly complex or specialized projects.
  • Adapts precedent and may make significant departures from traditional approaches to develop solutions.
  • Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

Responsibilities:

  • Implement the quality management system as well as compliance of the affiliate and affiliate supplier/distributor network, working collaboratively with regional staff and country managers.
  • Supplier / Distributor Management
  • Support review and approval of affiliate supplier / distributor network as part of the selection, qualification, and approval process. 
  • Prepare and review supplier / distributor Quality Agreements to ensure robust partnerships exist.
  • Support management of Approved Supplier / Distributor List and performance profiles
  • Manage, and maintain CAPA process for area, lead CAPA activities, proficiency in CAPAs and root cause investigations is required
  • Keep vigilance to ensure adherence to Quality Policy, Quality system procedures and establish Quality metrics
  • Support internal and external compliance Audits. Assures audit readiness of the affiliate regions and conduct pre audit checks. Assure compliance with applicable regulatory standards, ensuring the safety and efficacy of company products and successfully meeting the business needs and objectives of the division.
  • Support regional Management reviews
  • Work closely with relevant Divisional functions, Legal manufacturers, and local cross functional team to support business needs. Assures affiliates and affiliate supplier/distribution partners have adequate systems in place to store and distribute products
  • Must effectively communicate, prepare, influence, and negotiate both internally with commercial partners and externally with regulatory bodies and key cross divisional partners.
  • Excellent verbal communication skills appropriate for acting as a liaison between the company and its distributors/suppliers.
  • Ability to work independently and in groups; ability to work cross-functionally; ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action.
  • Ability to work independently with minimal supervision. Ability to work and interact with multiple cultures in different time zones.
  • Be proficient in use of personal computer and business/technical software (e.g., Microsoft Office).

Requirements

  • Bachelors Degree Preferably in the life or physical sciences, Engineering, Bioengineering or other science disciplines (Biology; Chemistry; Biochemistry; Clinical Chemistry; Med Tech: etc.) or substantial equivalent experience.
  • Minimum of 7+ years experience in Quality Assurance, Supplier Management, and/or Regulatory Affairs.  
  • Excellent verbal communication skills appropriate for acting as a liaison between the company and its distributors/suppliers.
  • Ability to work independently and in groups; ability to work cross-functionally; ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action. Ability to work independently with minimal supervision.
  • Ability to work and interact with multiple cultures in different time zones. 
  • Experience in the diagnostics (preferred), medical device, or pharmaceutical industry.

For more information on this role and a confidential discussion please contact Michelle Mc Inerney on

091 706 717 or email michelle.mcinerney@collinsmcnicholas.ie