RAQA Project Associate

Location Portage, MI Salary Competitive Description Our client is currently seeking a RAQA Project Associate RAQA Project Associate Description Plans, monitors and manages internal projects from initiation through completion.

Secures required resources and uses formal processes and tools to manage resources, budgets, risks and changes.

Manages projects to ensure on-time completion according to specifications and within budgeted costs.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.

Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.

Job requires an understanding and application of procedures and concepts of own discipline.

The job requires the ability to make judgements based on practice and previous experience.

This job typically requires a degree or equivalent and no experience.

RAQA Project Associate Additional Job Details Populate and review regulatory documentation based on research of labeling documents entailing use of tables in MS Word Support a time-sensitive project which requires modifications to legacy product labels Partner with team members in functional area using labeling technology software (Prisym ID) and and Windchill for document management.

Enter data into database structure following style guidelines and workflow within a regulated industry practices Partner with team in the execution of design, creation, approval, label format modifications and labeling documentation.

These are basic labels with text and barcodes.

Utilize a database driven label technology software while accurately populating data (text and graphics) into database Coordinate with a team member who procures language translations for labeling Proofread and review labeling executed by others within the functional area May participate in execution of label system validations Report project execution status to management Follow procedures as required per engineering change workflows and document archiving requirements EU Medical Device Directive (EU MDR).

Support regulatory documentation and modification of product labeling for compliance to new requirements.

Project is time-sensitive Collect and compile metadata for EU MDR eIFU requirement.

Use of spreadsheets required.

Ability to efficiently key information and review for accuracy essential.

RAQA Project Associate SkillsRoles Listening Skills, Intermediate, Preferred Problem Solving, Intermediate, Preferred Data Management, Expert, Preferred Organizational Skills, Intermediate, Preferred Attention to Detail, Expert, Preferred Customer Service, Intermediate, Preferred Meets Deadlines, Expert, Preferred Proofreading Editing, Expert, Preferred Written Communications, Intermediate, Preferred Contact tfetterjudge.com mailtotfetterjudge.com?subjectRAQA20Project20Associate This job and many more are available through The Judge Group.

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