Job Summary:

The Document Control Specialist is responsible for supporting and maintaining the QMS including Document and Record Control, QMS Logs, change control, personnel training, and assisting with Quality System and production related activities such as incoming inspection, maintaining Supplier Files, and routing various QMS records for approvals. Assist in planning of quality related projects in alignment with company goals.

Essential Duties and Responsibilities:

• Responsible for executing all document control activities including document control processing from number issuance to reviewing, approving, collecting approval signatures, closing of DCO, and filing/maintaining released documents and DCO logs.
• Responsible for issuing procedural training and maintaining all employee training files and training Matrix up to date.
• Store, index, and maintain Quality Records, including Complaints, CAPA files, internal audit files, and Design History Files as required. Maintain the Quality records document current.
• Maintaining, organizing, task tracking, and assisting with driving open items to closure for logs related to document control and quality such as Memo Log, External Standards Log, Rework Log, Returns Log, DCO Log, Document Number Request Log, etc.
• Maintains and organizes manufacturing records such as Lot History Records and Device History Records.
• Assists with QMS activities including supplier qualification and maintenance of certification records, administration of nonconformance and CAPA records and actions.
• As required, executes Quality inspection and material handling, such as receiving inspection, production inspection, final product release, and returned material handling and cleaning.
• Assist the Director of Quality Assurance with the preparation of information for Management Reviews and support of external audits.
• Provide guidance and training to Presidio employees and departments on Quality System processes and procedures.
• Comply with Presidio Medical’s quality system requirements as well as any applicable regulatory requirements, health and safety regulations, policies, and work practices.
• Other duties as assigned.

 

Qualification Requirements:
Experience:

• A minimum of 3 years of experience in quality operations in the Medical Device (or comparable) industry.
• Experience implementing or working in an electronic Quality Management System, admin experience preferred.
• Experience handling components/products preferred, i.e., incoming inspection, manufacturing, or complaint handling.

 

Knowledge/skills/Abilities:

• Knowledgeable of FDA (21CFR 820), ISO 13485
• Experience in implementing and managing document control systems
• The ability to work independently
• Excellent verbal and written communication skills
• Excellent problem-solving skills
• Excellent interpersonal skills and a spirit of teamwork

 

Education:

• BS/BA in an Engineering/Scientific discipline preferred.

 

Physical Demands:

• Varied sitting, standing, and walking.
• Ability to lift and carry 50lbs. or less.