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| Company: |
Global Technical Talent |
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| Job Title: |
Quality Engineer |
| Job category: |
Pharmaceutical |
| Job Location: |
Ireland |
| Job Reference Number: |
TMQE012909 |
| Job Description: |
HI.
I am currently looking for Sr. Quality Engineer for an opportunity with an extremely high profile Client.
Location : Athlone, Ireland
Duration : permanent
Pay rate : Open
Please send me a WORD Copy of your resume
dcooper(at)gttit(dot)com
Job Responsibilities:
§ Provide quality engineering support in the development and manufacture of disposable medical devices.
§ Work with manufacturing engineering to ensure necessary process controls are in place.
§ Represent Quality Assurance on Engineering Change Orders (ECO) and Material Review Board (MRB).
§ Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust.
§ Gather and report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
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Skills Required:: |
Job Qualifications:
§ BS in Engineering discipline (ME, Plastics or Biomedical) and 2 – 5 years experience in Quality Assurance / Quality Engineering in the medical device field.
§ Experience supporting the design and manufacture of disposable medical devices.
§ Demonstrated experience with formal problem-solving methodologies and deductive skills.
§ Solid understanding of FDA QSRs, GMPs and ISO 13485 requirements.
§ Process qualification and validation (IQ/OQ/PQ) experience.
§ Experience with Risk Analysis (Design and Process FMEA).
§ Experience with root cause investigations pertaining to customer complaints.
§ Strong statistical / data analysis skills (Minitab).
§ Auditing (Internal and/or External) experience.
§ Clinical/field experience with catheter-based or cardiac assist devices.
§ Six Sigma knowledge and practical experience is a plus.
§ Experience with SAP is a plus.
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Language Requirements: |
English-Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-02-04 |
| Level of Education: |
Unspecified |
| Years of Work Experience: |
No experience |
| Company: |
Global Technical Talent |
| Contact Name: |
David Cooper / Gary Franks |
| Contact Phone: |
603-319-4879 |
| Preferred Method of Contact: |
E-mail |
| Preferred Language of Resume/Application: |
English |
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