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  • DUBLIN 2
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  • Job reference number:15329916
  • Client ID:RI/JO-1803-404215
  • Posted on:07-MAR-2018
  • Job type:PERMANENT


This position requires a Senior Quality Engineer with the ability to manage a very broad set of activities, as described below:

Sterility Assurance Quality system documentation shall meet the requirements of 21 CFR Part 820, ISO 13485, the European medical device directives, the Japanese Pharmaceutical Affairs Law, and other quality system regulations and standards as appropriate.
Complete Sterility Assurance transfer plans, sterilization and microbiology assessments, protocols and reports as per regulatory requirements.
Complete biocompatibility assessments, protocols and reports as per regulatory requirements.
Liaise with transfer leaders to co-ordinate product samples and scheduling with test laboratories.
Support cleanroom installation and qualification activities including protocol and report reviews with the applicable manufacturing sites.
Liaise with the manufacturing sites to ensure the procedures for cleanroom testing, product testing and final release associated with product transfer are complete.
Ensure microbial test methods are validated with the applicable laboratories.
Ensure proper communication and act as a liasonand partner with regulatory, quality, microbiology, sterilization, product development and sales & marketing personnel to insure project success.
Adhere to and ensure the compliance of Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
Represent Sterility Assurance at the Strategic Manufacturing Transfer leadership meetings.
Perform other duties requested by management.

Senior Quality Engineer Strategic Projects
Microbiology, Biology, Medical Technology or Other Appropriate 4 Year Degree.
8-10 years experience in irradiation and ethylene oxide sterilization methods with knowledge of steam and gas plasma sterilization methods desirable.
Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents.
Project Management skills and experience.

Experience with leading and participating in several projects concurrently.
Ability to accurately scope projects and consider the full impact of decisions and actions taken.
Experience with biocompatabilityassessments and test requirements.
Experience in cleanroom installation and qualification requirements.
Experience in water system and compressed air installation and qualification requirements.
Knowledge of microbial test methods.
Effective communicator of issues, of facts and ideas/solutions to senior members of the organization.
Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts.
Excellent interpersonal skills and ability to participate with cross functional teams in projects and innovation.
Ability to communicate and to present reports & ideas.
Functional expert in Sterilization & Microbiology understanding, with a passion for excellence.
Good business acumen.
Displays ownership of results and a drive to achieve.
Must be fluent in English and Spanish desirable (Native or bilingual proficiency).
Attention to detail and accuracy essential.
Complex problem solving skills for developing creative solutions and meeting objectives are required.
Manage personnel directly or indirectly to achieve the objectives of the applicable strategic project.
Self motiviatedto achieve compliant results.

The successful candidate must be prepared to travel as the role demands (typically up to 25% of the time). International travel required.

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