Registration Support Certification Engineer

Adecco Technical has an immediate need for a Registration Support Certification Engineer for one of our clients in Irvine, CA.
This is a Direct Hire position.

The Regulatory Affairs team seeks an individual who possesses five years experience working in product development / Design Control in medical instrumentation and consumables. Assist with regulatory standards? certification test strategies, data analysis and reports. Contribute to unique country specific registration tests that may be raised and required after product release.

Responsibilities:
Responsibilities are to support of Research & Development projects and product releases:
- Provide support in documentation & product evaluation to expedite registrations.
- Help expedite safety standards certification for rapid registrations (& thus marketing) in Canada; Regions of the World, etc.
- Assist with FMEA to support safety & reliability evaluation.
- Update verification & validation records to reflect changes.

Requirements:
- BSEE
- Experience with design control processes used in a medical instrumentation and consumables environment
- Familiarity with medical instrument development and the associated quality process
- Hands-on experience in coordinating test set-ups.
- Knowledge of safety & environmental tests and standards used for registrations
- Computer literate and quick study with new systems and programs
- Experience working with cross-functional teams
- Excellent written and verbal communications skills
- Exceptional organizational skills
- Understanding of ISO 14971 (Risk Management), Verification & Validation principles, EU Medical Device Directive & FDA QSR.

Preferred Qualifications:
- Lab View; JD Edwards and/or Product View
- Development of test routines

Only local candidates will be considered.
Qualified candidates should e-mail their resume to bashar.zoma@adeccona.com
Adecco is proud to be an Equal Opportunity Employer



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