Document Specialist - 6 Month Contract - $17/HR Minimum

Description

This position has the responsibility to plan and execute Manufacturing Engineering activities to support the remediation of products relative to the European Medical Device Regulations (MDR), ensuring products maintain compliance with quality and regulatory requirements, and ensure uninterrupted commercial access to the European Union market. They will be an integral team member on the Technical Documentation and Labeling EU MDR Workstream Team in order to update, reconcile or prepare product technical documentation focusing specifically on change control submissions of drawings and labeling.

This position is located in Plymouth, MN. The pay for this positions starts at $17/HR and increases, DOE. FDA and EU MDR experience is highly preferred. Please apply if you meet the below qualifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
??? Support a program of Change Orders (CO) projects to implement the technical documentation, product/component specifications, packaging and labelling changes required in support of the EU MDR program for the Medivators electrical mechanical production line.

??? Generate, approve and/or manage CO documentation and associated activities, identifying impacts of proposed changes on processes including packaging configuration and other design / technical file inputs.

??? Prepare or update manufacturing specifications and design drawings, and act as a consultant in the preparation of final or modified drawings in line with MDR requirements

??? Review and understand global regulatory requirements (FDA, EU MDD, MDR, Health Canada, etc.) with emphasis on EU MDR 2017/745.

??? Assist in processing basic CAD drawings

??? Collaborate with cross-functional teams to prepare related technical documentation for Change Order publication and approval, ensure compliance to applicable standards/requirements, and confirm correct/efficient implementation.

QUALIFICATIONS REQUIRED FOR POSITION:
??? Minimum High School degree or equivalent required, Associate degree preferred

??? Preferred work experience in the medical device industry in a manufacturing related position with technical ability.
??? Ability to read and understand component/product specifications.

About Advantage Resourcing

Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.