QA Analyst

Job Description

Job Description

The purpose of the QA Analyst role is to support the company’s Quality Management System by maintaining accurate quality records, controlled documents, training documentation, complaint files, CAPA records, and other regulatory documentation. This position helps ensure documentation is complete, accurate, properly maintained, and compliant with applicable quality requirements.

  Position Description/Responsibilities:

·         File electronic and hard copies to each employee files

·         Assess training needs for new and existing employees (Temp or Full time)

·         Assist documentation control with filing Quality Documents.

·         Assist maintaining Device Master Records hard and electronic copies.

·         Assist create and maintain Complaints, complaint log and closure status.

·         Assist maintaining CAPA record and ensure completion.

·         Assist Document Control in creating, routing and releasing documents within the QMS.

·         Assist owners in creating Document Change Requests (DCR) and/or Engineering Change Orders (ECO)and the associated file.

·         Assist close DCR and ECO’s after verifying that they are complete.

·         Compare redlines to complete engineering drawings, BOMs, literature, and other documents for accuracy.

·         Maintain remote hard copies of controlled documents as required.

·         Assist maintaining calibration data, records, and certificates.

·         Format and revise Instruction for Use and other controlled Customer oriented documents as directed.

·         Perform other tasks as assigned.

Requirements:

·         Ability to use available resources to track document history and to research problems.

·         Excellent reading and written English skills.

·         Good computer skills.

·         Ability to use Word, Excel, and MS Outlook

·         Excellent problem analysis and problem solving

·         Excellent attention to detail.

·         Excellent skills in organization and presentation.

·         Hands on experience coordinating training, facilitation or similar roles

Preferences:

·         B.A. Degree or equivalent experience (3 years within medical device ISO 13485/ISO 9001 environment) .

·         2 years experience in control of documents in an FDA regulated industry.

AJR Enterprises, LLC is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry. Headquarters and manufacturing are located at our 180,000 square foot facility in St. Charles, Illinois.

We are focused on delivering the highest quality products and providing exceptional customer satisfaction in the medical device industry.

Company Description

AJR Enterprises, LLC is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry. Headquarters and manufacturing are located at our 180,000 square foot facility in St. Charles, Illinois.\r\n\r\nWe are focused on delivering the highest quality products and providing exceptional customer satisfaction in the medical device industry.