Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie

Senior Design Assurance Engineer (Packaging)

Senior Design Assurance Engineer (Packaging)

My MNC medical device client are searching for a Senior DA Engineer to provide on-going design and quality assurance expertise and leadership to the EMEA Packaging & Labelling Design & Development Centre of Excellence team.

The team is responsible for the design, development and validation of packaging and labelling configurations across the EMEA region, in support of the development of orthopedic implants and associated devices that are complex in nature.

Duties of the role:

  • Provision of on-going regulatory compliance, risk management, design control, quality systems and overall design assurance expertise and leadership to the EMEA Packaging & Labelling Design & Development Centre of Excellence team on an on-going basis.
  • Provision of regulatory and quality systems leadership to the team as it transitions to Packaging & Labelling Design Ownership (Design Authority).
  • Liaison with corporate, local and EMEA sites quality systems and regulatory affairs personnel to ensure team’s compliance and to drive alignment and harmonization.
  • Monitoring of the release and updates to regulatory & quality standards, regulations and policies, execution of gap analysis, communication of changes to the team and driving compliance.
  • Driving the implementation, maintenance and update of procedures that ensure packaging and labelling design controls are met.
  • Creating and maintaining risk management documentation.
  • Providing independent quality review for design reviews, project design plans, risk management, design validation protocols & reports for both design and development projects.
  • Support the team in their design & development activities, carried out on behalf of other EMEA sites.
  • Support the establishment of a Packaging Testing Laboratory in the Galway site.
  • Support the integration of the team into the Galway site QMS.
  • Provide direction for documentation Control, CMS (Change Management System) and CAPA processes.
  • Manage communications with regulatory bodies such as BSI.
  • Provide leadership in the preparation for and during audits. Take the lead and front the team’s participation in audits.

Requirements:

  • Degree qualified. 
  • 5+ years’ relevant experience in a Design Assurance – Quality Engineering field in a medical device or other FDA 21 CFR 820 or ISO 13485 regulated environment.
  • Must have experience in the preparation for and participation in ISO audits.
  • Experience in packaging and labelling design assurance very desirable.
  • Qualified auditor to FDA 21 CFR 820 or ISO 13485 desirable.

For further information on this Senior DA role in Galway please contact Amanda Reynolds on 0860468858/ technical@hero.ie

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.

Amanda Reynolds

JOB-11319

Senior Design Assurance Engineer (Packaging)

Amanda Reynolds

Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie
mobile +353 86 046 88 58
linkedIn profile click here

Senior Compliance Specialist

Sligo

Senior Compliance Specialist My client a leading pharmaceutical company in Sligo is looking to hire a Senior Compliance Specialist on…

 

Read More

MDR – MDR/Vigilance Specialist

Galway

Title                  MDR/Vigilance Specialist Duration:         12 months Location:         Work from home / Ballybrit Galway Start Date:       ASAP…

 

Read More

IT Business / Systems Analyst

Galway

Title     IT Business/Systems Analyst Summary Our client, a medical device company in Galway is currently looking to recruit an…

 

Read More