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EU MDR Manufacturing Engineer

2 months ago


West Valley City, United States Intellectt Inc Full time

Role: Manufacturing Engineer III

Location: West Valley City, UT - 84119

Duration: 12 Months

Job Description:

Flexible Work Model - HM wants this candidate on site for executions and at the beginning. Then there will be opportunity for this worker to work remote a few days a week

Interview process - 1 onsite interview with Travis (30-45 min) then will meet with Bob (30-45 min) and site tour.

EUMDR Special Project

The position will need to help execute gap assessments against EUMDR. So preferably candidates who are more familiar with that standard would be the preference. The individual should still have a strong validations background as well. After the gap assessment, the validations will take place.


Responsibilities:

Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.

Provide statistical analysis of the date to support the reports. Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.

Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel. Work on project teams with other internal departments, external vendors, and customers as required.

Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.

Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.