Position Description:
The experienced Senior Documentation Control Coordinator supports our rapidly expanding domestic and international medical product development business. The experienced Senior Documentation Control Coordinator establishes and maintains QSR/ISO 13485 Document Control Systems compliance.

Responsibilities:

Provide input in controlled document management and quality records management
Manages daily document control activities and performs drawing and document revisions
Responsible for document control, oversight, alignment and execution of technical documents with internal operations and external sources
Documents will include: master record, manufacturing process instructions, finished product specifications, packaging specifications, finished goods release testing, test methods, development protocols, validation, and process validation
Process documents for revision and approval and coordinate the configuration control process
Trains staff on document control processes and procedures
Assist to implement systems and modules for electronicdocumentation change control and training
Oversee and executes elements of the training process, including onboarding of new hires, scheduling training within the Document Control System, maintaining training records and reporting
Administer Document Changes and coordinate review, approval and releases. Interface with all users to ensure all document updates are clear and correct.
Assist in process improvement and corporate initiatives as assigned by the manager
Other quality systems activities, such as owning continual improvement, CAPA, and audit findings, as assigned by the manager

Requirements: B.S degree and/or the equivalent experience as a Document Control Analyst in a manufacturing or design environment (6-8 years). S/he possesses a thorough knowledge of drawing, specification and bill of material development in a regulated industry. A significant degree of knowledge in the following areas is also required:

Medical device GMPs, and QSR requirements or other relevant regulated industries for documentation
Knowledge of CAD, PLM and ERP Systems

Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:

Successful communication skills, and assertive decision-making ability
Flexibility to multi-task and perform a wide range of activities
Excellent computer skills, including MS Office proficiency and document control software
High attention to detail