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QA Manager Biologics
Dublin West
Senior CRA
Product Specialist (Microbiology)
Republic of Ireland
R&D Engineer
QA Manager
API Purchaser
R&D Engineer
QA Manager
Dublin West
Dublin City Centre
Snr QA Officer
Dublin North
Program Manager
Snr QA Specialist
Dublin South
Head of Quality
Dublin West
QA Manager
Dublin North
James Cassidy
Life Science

+353 1 5079250
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Search Results for Quality Engineer
Job Title. Location Salary Actions

Quality Systems Engineer.

Quality Systems Engineer Job purpose Improve and Maintain the quality management system (QMS) in line with ISO13485, ISO9001, 21CFR 820 and Medical Devices Directive. Key responsibilities will include (but are not limited to) the following: • Quality system compliance to ISO13485, ISO9001, 21CFR 820 and Medical Devices Directive • Ability to implement and improve a QMS • Maintain and support the Internal Audit System • Conduct Internal Audits • Quality System support in Audit back rooms for Regulatory and Corporat...

Location: Westmeath,
Quality Systems Engineer.
Westmeath Not Disclosed

Quality Engineer

Our client, a global healthcare manufacturer, is seeking a Quality Engineer to join their operations in Dublin. The candidate will report to the Quality Enginee

Location: Dublin,
Quality Engineer
Dublin Not Disclosed

Advanced Quality Engineer

Our client is a Fortune 500 medical technologies firm who is currently looking for an Advanced Quality Engineer to join their team. The role reports to the Adva

Location: Cork,
Advanced Quality Engineer
Cork €100000+

Quality Engineer

QUALITY ENGINEER Our multinational client in South Dublin requires a Quality Engineer. Reporting to the Senior Quality Engineer duties will include management and execution of process validation studies, active participation in non-conformance investigation, process improvement projects, project management, application of SPC to current production processes and liaison with key customers. Role/Responsibilities: • Be a key driver of cGMP practices within Operations and Quality divisions • Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820...

Location: Dublin,
Quality Engineer
Dublin Not Disclosed

Senior Validation Engineer

Senior Validation Engineer Our medical device client in Galway requires a Senior Validation Engineer on a permanent basis. The successful candidate will work on planning and execution of all validation activities related to new product introductions. Role/Responsibilities: • Lead all validation activities for the company. Develop project plans for the all validation activities and report to management on the implementation of the plans. • Review all validation processes and documentation at sub-contract manufacturing facilities. • Generate validation d...

Location: Galway,
Senior Validation Engineer
Galway Not Disclosed
Other Medical Device Jobs
Job Title Location Salary Actions
QA Manager Biologics Dublin West €70000 - €80000
Director Device Program Lead Dublin Not Disclosed
Senior R&D Engineer Dublin Not Disclosed
Snr Mechanical Engineer contract Dublin Not Disclosed
Quality Manager Combination Products Dublin Not Disclosed
Validation Engineer Limerick Not Disclosed
R&D Engineer Dublin Not Disclosed
Research and Development Compliance Specialist Galway Not Disclosed
Biologics Snr PM contractor Dublin South Not Disclosed
Manufacturing Engineer Galway Not Disclosed
Programme Manager Cork €60000 - €65000

Quality Engineer Career Profile

Quality Engineer

Designs, installs, and evaluates quality assurance process sampling systems, procedures, and statistical techniques; designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards; recommends revision of specifications when indicated; formulates or helps formulate quality assurance policies and procedures. May conduct training on quality assurance concepts and tools. Interfaces with all other engineering components within the organization and with customers and suppliers on quality related issues.

Typically a quality engineer has a degree in engineering or in a quality related discipline.

Key Skills a Quality Engineer should possess are

  • Coordinating the activities of the Quality resources allocated to the department to ensure optimal efficiency and compliance with all regulatory requirements.
  • Drive and maintain cGMP practice within the department.
  • Preparation, review and approval of technical documentation
  • Ensure all related CAPA's are completed in compliance with all regulatory and procedural commitments.
  • Drive root cause analysis of non conformances with the department subject matter experts.
  • Become an active member of the site internal audit team, liaising with Regulatory auditors
  • Devise and implement Six Sigma continuous improvement projects
  • Ensure support area operates in accordance with current best practice.
  • Act as customer liaison contact for given key customers.
  • Review, analyse and report on relevant customer complaints.
  • To carry out Quality and Regulatory Compliance functions within the Quality Engineering Team