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November 12 2018

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Job Opportunity: Senior Design Assurance Engineer:Fastnet ? The Talent Group

Job description:

Senior Design Assurance Engineer

Fastnet - The Talent Group


   » Wexford
   » Not disclosed
   » Permanent full-time
   » Updated 15/10/2018
   » Dara Bradley this job is expired SaveSave Apply Now

Job detail


Leading Medical Device manufacturer in Wexford have a requirement for a Senior Design Assurance Engineer with responsibility for developing, maintaining and improving validated test methods for all newly designed products. Amazing opportunity!
 

Leading Medical Device manufacturer in Wexford have a requirement for a Senior Design Assurance Engineer. Amazing opportunity, permanent function with excellent career prospects and package.
The Senior Design Assurance Engineer will be responsible for developing, maintaining and improving standardised clinical significant validated test methods for all newly designed and newly introduced products that are agreed with the R&D and Engineering NPI groups in the planning phase of the project. Provide input and execute strategies for product verification and process validation. Provide guidance for analysis of new product designs and processes for safety and effectiveness.

Key The main responsibilities are:
   » Ensure continued compliance with all Regulatory Standards. This includes ISO 13485- ISO 11070- FDA QSR
   » Ensuring continued compliance with DMR
   » Process Validation Guidance from the Global Harmonization Task Force
   » Drive the site validation function in the development and provisions of documentation for the qualification (IQ/OQ/PQ/PPQ) related to agreed Plant validations.
   » Working as a member of the plant project team to review what projects require validation.
   » Assist with URS development for software validation projects.
   » Interact with other departments conducting the validations before protocols are written and again to review the validation data for the validation report.
   » Ensure that all data, results and information connected with qualification and validation data provided for reports are in conformity with written procedures.
   » Implement, deploy and revise as applicable all Validation procedures.
   » Assist in the development of Master Validation Plans and Validation Strategies. Ensure that the plant master validation list is kept up to date and that approved records for all the validations listed are available in hard copy for audits and that all are available to view on EDM.
   » Provide a system for documenting the annual validation activities and the agreed schedule.
   » Writing and arranging approval of validation protocols and reports. Update validation protocol/reports with deviations report.
   » Lead the clinical significant validated test methods for all newly designed and newly introduced products that are agreed with the R&D and Engineering NPI groups in the planning phase of the project.
   » Provide cover for the QA Lab in relation to testing and aid in the smooth running of the lab.
   » Plant audits: Interacting and presenting validation documentation during FDA, NSAI, Corporate and customer audits.
   » Conduct training in Validation Methodologies and related procedures as required.
   » Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements
   » Be an active member of the team and work with all employees to develop a world class lean manufacturing system.

Requirements:
   »Engineering or Science Degree.
   »Strong validations practice, Complaints practice , Statistical techniques/expertise, Excellent Quality systems and preparing technical reports practice
   » expertise of Computer System Validation, Test Method Validation and/or Six Sigma/Leader auditor qualification will be a distinct advantage.
   » practice in Design Assurance with the capability to develop clinical significant validated tests methods
   » expertise of engineering theories and methods, demonstrating an aptitude for analysis and problem solving.
   » Good working expertise of statistics and be comfortable with using Minitab for Data Analysis and satirical Distribution / Graph techniques etc.
   » Good PC expertise and the capability to use Microsoft Project to track and manage significant projects.
   » capability to communicate and work with people inside and outside the department. capability to co-ordinate, plan and organise in a timely manner. Rigorous attention to detail.
   » capability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the function.

Fastnet has a strict confidentiality policy - please be assured that your details will never be mailed to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists
Ref: JO-1808-63709_1539599120
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Fastnet - The Talent Group


   »  


   » Eastgate Village, Eastgate Business Park, Little Island, Cork
   » 021 4509200
   » jobs@fastnettalent.com
   » http://www.fastnettalentgroup.com



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Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Wexford
Company Type Employer
Post Date: 10/15/2018 / Viewed 3 times
Contact Information
Company: Fastnet ? The Talent Group
Contact Email: jobs@fastnettalent.com


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