Document Control Specialist

Job Description

Job Description

Document Control Specialist

Position Summary :

Manages, implements, and maintains company’s Document Control, Training System, and e-QMS database (QT9). Coordinates documentation activities through change management and database interface. Follows established procedures and policies to meet the demands of document control and training compliance in a regulated medical device company.

Key Responsibilities :

Responsible for overall coordination of Document Control functions and Training program

Supports the document change control process, including the initiation, review, approval, and implementation of changes to controlled documents

Manages Change Control Board (CCB) meetings and drive continuous improvements initiatives

Monitors and tracks Quality System training assignments to ensure on-time completion and data maintenance for reporting training metrics.

Collaborates with HR to support the employee onboarding and offboarding processes

Serve as a global administrator and Subject Matter Expert (SME) of QT9

Assists in the development, management, and troubleshooting within QT9, identifying and implementing continuous improvements

Supports the record retention program of quality documentation

Supports quality systems elements such as auditing, customer complaint investigations, and special projects at both the Valencia and Ventura locations

Other duties as assigned by Manager

Requirements :

Prefer High School Diploma with 1-2 years’ experience in documentation control systems, with preference in coordination and administration of systems within FDA QSR / ISO requirements.

Prefer a strong background in Good Documentation Practices and ALOCA Principles.

Working knowledge of Microsoft Word, Excel and Adobe Acrobat required

Detail-oriented with strong organizational skills

Must be able to complete multiple tasks during the workday

Excellent Customer Service and teamwork skills

Proficient in communication and working with teams that consist of diverse personnel at various levels and locations

Works well under pressure with changing priorities and deadlines

Advanced English language skills : writing, grammar, proofreading & redlining

Full understanding of documentation control systems within a medical device company certified to ISO Standards and FDA QSR We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business need.