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About US:

Established in 2006, Orpine Inc is an international Minority Business Enterprise (MBE) consulting company with offices in Georgia, North Carolina, California and India.

When it comes to staffing solutions, our strong ties to various talent pools allow us to fulfill the contract and permanent positions for any size company, ranging from Global 2000 Companies to implementation partners.

Currently we are hiring for below mentioned position that our client has.

Packaging and quality engineer

Description-:

SCOPE & ENGAGEMENT

Scope: A Quality Engineer, Packaging Engineer, or both to assist on enhancing the Design History File (DHF) documentation, any data sets and applicable technical rationales based upon the BSC-reviewed and approved conformity assessment and observations to assure compliance with BSC Quality System to support EU MDR product transitions.

Experience Level: Entry level to Senior Level (5+ years' experience)

SERVICES; DELIVERABLES, APPLICATIONS & REQUIREMENTS. Service Provider shall perform the following Services, and shall provide BSC with the following

Deliverables:

A. Services:

This resource will be focused on but, not limited to, the device packaging elements within the design controls framework. This individual will be the packaging representative on the Project Core Teams responsible for all deliverables required of package engineering. The responsibilities will include teamwork, establishing components and labeling documentation, and all activities required to implement the DHF elements within the Boston Scientific documentation management system (PLM).

The execution of this work will be undertaken remotely. Hence, attendance to video-conference calls will be required.

B. Deliverable(s):

Design Inputs:

User Need and Design Requirement: Definition, clarification, traceability and alignment with harmonized standards (e.g. ISO 11607).

Design Outputs:

Definition, clarification, traceability between Design Requirements/Risk Control Measures and Design Outputs,

Design Verification:

Test Sample Traceability and conditioning
Technical rationales
Design Verification studies and coordinating testing
Design Verification Master Plan

Design Changes:

Design Change Assessments (DCA)

Standard Compliance:

Standard Compliance Checklist

Service Provider shall provide Boston Scientific the following deliverable(s):

A Package engineer or Quality engineer capable of performing the scope of work
A cooperative professional person that is a team player
All documentation and other activities not limited to the list above

RFP Deliverables:

3 Candidate Resumes
Pricing Template

For more exciting opportunities join us on linkedin https://www.linkedin.com/company/orpine-inc/
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Orpine

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