Vakante Jobangebote finden Sie unter Projekte.
Mechanical Engineer - 3 yrs Quality exp - San Diego - med Device
Eingestellt von Real Staffing Group aus Frankfurt am Main
Gesuchte Skills: Engineering, Design, Engineer
Projektbeschreibung
Job requirements:
2-3 yrs of experience in Quality Assurance!
Review and retrieve relevant information from several resources [e.g. risk assessment, hazard analysis documents (FMEA, PFMEA, etc.), design input and verification documents, DHFs, etc.] and transfer the information to several spreadsheets required by the IEC 60601-1 3rd Edition standard. Provide support to the IEC Team and work closely with QA/RA, Engineering and Marketing personnel to effectively gather information in order to complete all product submissions.
Requirements : Preferred background:
* Degree in Mechanical or Electrical Engineering with QE background.
* Engineering experience in the medical device field, having worked with verification/validation, hazard analysis and risk analysis protocols, reports, procedures and work directions according to Quality System Regulations and FDA and ISO standards.
* Quality Systems: QMS design and implementation (ISO13485), Equipment validation (IQ, OQ and PQ) and Risk management/mitigation (using ISO14971)
* Quality Control: IQC, In-process QC and Final release/OQC process design (using AQL), implementation and validation (OQ and PQ),
* Some experience working in Manufacturing Engineering in production lines on process improvements and problem solving ideas.
* Some exposure to performing failure analysis of field-returned product, investigation of Customer Complaints, and Corrective Action and Preventative Action (CAPA). Change order requests for changes to existing products.
Keywords: medical device, mechanical engineer, quality, quality assurance, iso, electrical engineer, validationTo find out more about Real Staffing please visit www.realstaffing.com
Projektdetails
-
Einsatzort:
San Diego, California, Vereinigte Staaten
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Ingenieurwesen/Technik