Job Summary:

The Sr. Quality Systems Specialist is responsible for supporting and maintaining the QMS including nonconformance, CAPA, internal audit, supplier management, change control, training, and production-related activities such as incoming inspection, rework and deviation handling. Assist in planning of quality-related projects in alignment with company goals.

Essential Duties and Responsibilities:

• Responsible for supplier management activities including qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing the Supplier Corrective Action Request (SCAR) program

• Responsible for CAPA management from CAPA generation to investigation, implementation of corrective action, verification of effectiveness, and closure

• Responsible for maintaining the Purchase Order log and overseeing the purchase order template and process

• Responsible for managing the internal audit schedule and execution, including completion or guiding completion of audits, and addressing any findings

• Assist the Director of Quality Assurance with the preparation of information for Management Reviews

• Support document control activities including document change control processing, and maintenance and retention of Quality Records, such as nonconformance records, CAPA files, and internal audit files, manufacturing records, and Design History Files

• Maintain Quality Logs for applicable Quality Records, such as the nonconformance Log, CAPA Log, Rework Log, etc.  

• Provide guidance and training to Presidio employees and departments on Quality System processes and procedures

• Support Quality Assurance production activities such as incoming inspection, quality review of manufacturing device/lot history records, and final product release

• Comply with Presidio Medical’s quality system requirements as well as any applicable regulatory requirements

• Comply with all health and safety regulations, policies, and work practices

• Other duties as assigned
  

Qualification Requirements:

Experience:

• A minimum of 5+ years of experience in quality operations in the Medical Device industry

•  Experience generating procedures from scratch and developing change and risk justifications

• 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, and ISO14971

• 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.