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Details

Senior Sterilisation Quality Engineer


Reference:AMCK-531340 Location: Westmeath
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Senior Sterilisation Quality Engineer
Our client, a medical device organisation are currently recruiting for a Senior Sterilisation Quality Engineer to join their team on a permanent basis. The Senior Sterilisation Quality Engineer will support sterility assurance activities for the International region in compliance with ISO13485, 21CFR820, European Medical Device Regulation, Japanese PAL and related sterility assurance ISO standards.

Responsibilities
• Ensure the Sterility Assurance Quality system documentation 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
• Comply with Global Quality System requirements
• Complete Sterility Assurance plans, sterilization and microbiology assessments, protocols and reports as per regulatory requirements
• Liaise with manufacturing sites across the International region, collaborating with local resources to complete sterility assurance validation activities
• 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 are compliant
• Support product transfer activities within the International region
• Ensure microbial test methods are validated with the applicable laboratories.
• Ensure proper communication and act as a liaison and partner with regulatory, quality, microbiology, sterilization, product development and sales & marketing personnel for sterility assurance projects
• Sterility Assurance lead for notified body and competent authority audits

Requirements
• BSc or BEng
• 8-10 year’s 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
• 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 in cleanroom installation and qualification requirements
• Knowledge of microbial test methods
• Effective presenter of facts and ideas
• 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
• Displays ownership of results and a drive to achieve
• Attention to detail and accuracy – essential
• Complex problem-solving skills for developing creative solutions and meeting objectives are required
• Lead auditor qualification desirable
• Available

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252