Lead Document Control Specialist - Regulatory & QA On-site

Matlen Silver; Portage (MI); On-site; USD 57,859 - 59,236; Full time

Job summary

A quality management consultancy firm is seeking a Lead Document Control Specialist in Portage, MI, for an 18-month contract. The role involves overseeing document control processes and ensuring compliance with regulatory requirements. Candidates must have a Bachelor's degree and a minimum of 4 years in Quality or Regulatory Affairs. Strong organizational and communication skills are essential for this position, which is critical in maintaining quality documentation within medical equipment manufacturing.

Qualifications

• Minimum of 4 years in a Quality or Regulatory Affairs environment.
• Able to gain knowledge of U.S. and international medical device regulations.
• Fluent in written and spoken English (B2 level or higher).

Responsibilities

• Manage all activities related to document routing and release.
• Ensure archiving and secure storage of documentation.
• Serve as the Subject Matter Expert (SME) for document control.

Skills

Organization skills

Effective communication

Data analysis

Education

Bachelor’s degree or equivalent

Tools

Document management tools

Job description

A quality management consultancy firm is seeking a Lead Document Control Specialist in Portage, MI, for an 18-month contract. The role involves overseeing document control processes and ensuring compliance with regulatory requirements. Candidates must have a Bachelor's degree and a minimum of 4 years in Quality or Regulatory Affairs. Strong organizational and communication skills are essential for this position, which is critical in maintaining quality documentation within medical equipment manufacturing.