Document Control Specialist

Job Description

Job DescriptionDocument 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:
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Responsible for overall coordination of Document Control functions and Training program
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Supports the document change control process, including the initiation, review, approval, and implementation of changes to controlled documents
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Manages Change Control Board (CCB) meetings and drive continuous improvements initiatives
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Monitors and tracks Quality System training assignments to ensure on-time completion and data maintenance for reporting training metrics.
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Collaborates with HR to support the employee onboarding and offboarding processes
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Serve as a global administrator and Subject Matter Expert (SME) of QT9
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Assists in the development, management, and troubleshooting within QT9, identifying and implementing continuous improvements
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Supports the record retention program of quality documentation
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Supports quality systems elements such as auditing, customer complaint investigations, and special projects at both the Valencia and Ventura locations
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Other duties as assigned by Manager
Requirements:
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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.
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Prefer a strong background in Good Documentation Practices and ALOCA Principles.
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Working knowledge of Microsoft Word, Excel and Adobe Acrobat required
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Detail-oriented with strong organizational skills
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Must be able to complete multiple tasks during the workday
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Excellent Customer Service and teamwork skills
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Proficient in communication and working with teams that consist of diverse personnel at various levels and locations
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Works well under pressure with changing priorities and deadlines
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Advanced English language skills: writing, grammar, proofreading & redlining
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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.