Job ID: 7800
Job Title: QA Specialist
Location: Rockaway, NJ

QA Specialist

Location: Rockaway, NJ
Job Type: Full-Time

About the Opportunity

A growing medical device manufacturing organization is seeking a detail-oriented QA Specialist to support Quality Systems and Document Control activities within a regulated production environment. This individual will play a key role in maintaining controlled documentation, supporting training compliance, and partnering cross-functionally with Quality, Regulatory, Engineering, and Manufacturing teams.

This is an excellent opportunity for someone with experience in document control, quality systems, and FDA-regulated manufacturing environments who enjoys working in a collaborative and fast-paced setting.

Responsibilities

• Support the initiation, processing, and execution of Document Change Requests (DCRs) for new and revised controlled documents
• Maintain document control systems, master files, and document archives in accordance with established procedures
• Assist in drafting, formatting, editing, and reviewing controlled documents including SOPs, work instructions, policies, forms, and related quality documentation
• Coordinate document review and approval workflows with cross-functional stakeholders
• Support employee training administration by maintaining training matrices, assigning training, and ensuring training records remain current and compliant
• Communicate with internal departments to gather and distribute documentation-related information
• Provide documentation support to Quality Assurance, Regulatory Affairs, Engineering, and Manufacturing teams
• Ensure compliance with document control procedures including version control, approval routing, and archival processes
• Assist with deployment and tracking of training materials across the organization
• Support additional Quality Systems and Quality Assurance activities as assigned

Qualifications

• Bachelor’s degree in a scientific, technical, or related discipline preferred
• 2–5 years of experience within a regulated manufacturing environment, preferably medical device
• Experience supporting document control, quality systems, or training coordination activities
• Working knowledge of FDA Quality System Regulations (QSR) and regulated documentation practices
• Familiarity with SOP management, controlled documentation, and training record maintenance
• Strong organizational skills with the ability to manage multiple priorities simultaneously
• Detail-oriented with strong written and verbal communication skills
• Proficiency with Microsoft Office and electronic document management systems preferred

Preferred Experience

• Medical device manufacturing experience
• Exposure to ISO 13485 environments
• Experience working within cross-functional Quality and Manufacturing teams
• Familiarity with electronic Quality Management Systems (eQMS)

Why Join

• Opportunity to contribute within a growing medical device organization
• Collaborative and team-oriented environment
• Exposure to cross-functional quality and manufacturing operations
• Ability to make a direct impact on quality and compliance initiatives