Quality Assurance & Documentation Specialist

Regulatory Jobs; Rockaway (NJ); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Regulatory Jobs is seeking a detail-oriented Document Control Specialist to implement and adhere to control procedures for medical device documentation in New Jersey. You will format and edit documents related to product development, quality assurance, and manufacturing processes.

You will coordinate reviews, assist with DCRs, and support training deployment while maintaining training records. A Bachelor’s degree with 2–5 years of related experience and GAS knowledge are preferred.

Formación

• Bachelor’s degree or equivalent practical experience in a medical device setting.
• Knowledge of US FDA Quality System Regulations (QSR).
• Self-starter with ability to manage multiple projects simultaneously.
• Proficient in MS Excel and MS Word.

Responsabilidades

• Assist with initiating and executing Document Change Requests (DCR) and maintain Document Master files.
• Draft and review policies, procedures, work instructions, and related controlled documents.
• Coordinate training plans and records for new hires and existing staff.
• Ensure timely communication with departments to disseminate documentation needs and support QA/Regulatory activities.

Conocimientos

Document control

Version control

MS Excel

MS Word

Multi-project management

Educación

Bachelor’s degree

Equivalent combination of education and experience

Herramientas

Grand Avenue GAS

Descripción del empleo

Regulatory Jobs is seeking a detail-oriented Document Control Specialist to implement and adhere to control procedures for medical device documentation in New Jersey. You will format and edit documents related to product development, quality assurance, and manufacturing processes.

You will coordinate reviews, assist with DCRs, and support training deployment while maintaining training records. A Bachelor’s degree with 2–5 years of related experience and GAS knowledge are preferred.