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SENIOR QUALITY ENGINEER - GALWAY
Company:ICDS RECRUITMENT |
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Job Reference Number |
14297857 |
Client ID: |
RI/AM11201 |
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Posted On: |
Mar 18 2010 |
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Location: |
GALWAY |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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In this role you will act as an integral member of the team representing quality engineering in design and development of and changes to medical device products, and facilitate the application of design controls. Translate Quality Standards into processes and procedures, and apply these to the new product design process.
RESPONSIBILITIES:
1. Participate with R&D in the development of and/or review proposed new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product requirements.
2. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation by providing leadership to the team with respect to regulatory requirements of new product development and/or product changes.
3. Be highly engaged to ensure a successful transfer of new products to production the facility, and/or changes to existing products are properly implemented. Review production processes for quality of validation through IQ, OQ, and PQ activities.
4. Assist in the development of design and process verification and validation test plans. Ensure verification / validation results demonstrate compliance to medical device standards. Represent Quality Engineering in the approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions.
5. Provide training to project teams on verification/validation, statistical methods and design controls.
6. Accountable for product risk assessment efforts within product teams.
7. Participate in and/or review all team deliverables for Design History Files and Technical Files for conformance to applicable requirements.
8. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
9. Conduct internal quality system and supplier quality audits.
SKILLS/KNOWLEDGE REQUIRED:
At least 5-7 years of experience in a Quality Engineering role
Bachelor of Science degree in an engineering discipline (electronic engineering preferred)
Skilled in test plan development and root cause failure analysis
Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments
Good verbal (including presentation) and written communication skills, especially technical report writing
Ability to effectively work on project teams
Familiar with reliability analysis and test methods
Familiar with ISO 14971 or strong experience in risk evaluation techniques, such as FMEA and/or fault tree analysis
CQE certification - desired
