Document Control / CAPA Supervisor

Our client in the Ramsey area of NJ has an excellent HYBRID opportunity for a Document Control / CAPA Supervisor!

Responsibilities:

Oversee the Document Control program including the QMS training program.
Supervise two (2) Document Control staff, provide task management oversite and training / technical support / guidance.
Serve as CAPA administration including execution, tracking and follow-up of related CAPA activities.
Conduct biannual CAPA source analysis and make recommendations for CAPA initiation based on results.
Train Quality and Regulatory Affairs department members to identify and perform CAPA analysis, when applicable or assigned by the Department Head.
Perform product-specific complaint handling from initiation through customer follow-up, including MDR assessment, investigation, writing investigational summaries and customer letters, and coordination of monthly complaint updates with field teams.
Support, as assigned or applicable, various teams (i.e., product-specific marketing teams, Operations task management teams, etc.).
Serve as Subject Matter Expert during internal and external audits for Document Control, CAPA, complaints.
Provide support and/or backup for routine Operations and Contract Manufacturing activities, as needed or when assigned by the Department Head.
Oversee Global Trade System compliance HOLD release program.
Work with MRSZ Quality Center supporting Quality programs/needs, when assigned.
Work with Quality and Regulatory Affairs department members supporting continuous improvement of the QMS, as needed or when assigned by the Department Head.

Requirements:

Bachelor’s degree.
Prior supervisory experience.
5 or more years in medical device Quality or Regulatory Affairs, similar regulated industry experience may be considered.
Knowledge of FDA Medical Device regulations, Medical Device Single Audit Program and ISO 13485, experience with similar regulations or standards may be considered.
Prior FDA, MDSAP, or ISO 13485 audit experience preferred.

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