Specialist - Quality Assurance
electroCore, Inc., Rockaway, NJ, United States
Description
This position is responsible for:
Implement and adhere to document control procedures, including version control, document approval, and archiving.
Create and edit documents: Prepare, format, and edit documentation related to product development, quality assurance, and manufacturing processes.
Coordinate reviews: Facilitate the review and approval process for new or revised documents by coordinating with relevant departments or stakeholders.
Assist in development and implementation of the Document Change Requests (DCR) for the company’s controlled documentation.
Assist with the deployment of training materials to employees and maintain resulting training records.
Perform other quality‑related functions as assigned.
Requirements
Bachelor’s degree (B.A.) from a four‑year college or university; or two to five years of related experience and/or training in medical device manufacturing; or equivalent combination of education and experience.
Possess working knowledge of US FDA Quality System Regulations.
Self‑starter capable of managing multiple projects simultaneously.
Good computer skills; proficiency in MS Excel and Word.
Primary Job Responsibilities
Assist with initiation and execution of Document Change Requests for release of new or revised controlled documents with respective departmental personnel.
Maintain DCR and Document Master and location‑specific files in accordance with established policies and procedures.
Assist in drafting and reviewing new and revised documents, including policies, procedures, work instructions, and related controlled documents.
Assist with scheduling and execution of employee training with respective departments/function management by reviewing and maintaining training plans and records for new hires and current employees.
Communicate with various departments to gather and disseminate information related to documentation needs.
Support teams: Provide support to Quality Assurance, Regulatory Affairs, Engineering, and Production teams by ensuring they have access to necessary documentation.
Other duties as may be assigned by manager.
#J-18808-Ljbffr
This position is responsible for:
Implement and adhere to document control procedures, including version control, document approval, and archiving.
Create and edit documents: Prepare, format, and edit documentation related to product development, quality assurance, and manufacturing processes.
Coordinate reviews: Facilitate the review and approval process for new or revised documents by coordinating with relevant departments or stakeholders.
Assist in development and implementation of the Document Change Requests (DCR) for the company’s controlled documentation.
Assist with the deployment of training materials to employees and maintain resulting training records.
Perform other quality‑related functions as assigned.
Requirements
Bachelor’s degree (B.A.) from a four‑year college or university; or two to five years of related experience and/or training in medical device manufacturing; or equivalent combination of education and experience.
Possess working knowledge of US FDA Quality System Regulations.
Self‑starter capable of managing multiple projects simultaneously.
Good computer skills; proficiency in MS Excel and Word.
Primary Job Responsibilities
Assist with initiation and execution of Document Change Requests for release of new or revised controlled documents with respective departmental personnel.
Maintain DCR and Document Master and location‑specific files in accordance with established policies and procedures.
Assist in drafting and reviewing new and revised documents, including policies, procedures, work instructions, and related controlled documents.
Assist with scheduling and execution of employee training with respective departments/function management by reviewing and maintaining training plans and records for new hires and current employees.
Communicate with various departments to gather and disseminate information related to documentation needs.
Support teams: Provide support to Quality Assurance, Regulatory Affairs, Engineering, and Production teams by ensuring they have access to necessary documentation.
Other duties as may be assigned by manager.
#J-18808-Ljbffr