Position : Contract Quality Specialist I – Entry level

Location : San Antonio, TX

Duration : 6 Months contract

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Level Of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description:

Summary - Main Purpose of the Position

• Summarize in one or two sentences on why the positions exists and what the position is designed to accomplish.
• Staff Quality Systems Specialist I is responsible for development, implementation, and maintenance of the NASSC Quality Management System.
• The individual in this role must work cross functionally both horizontally and vertically within the organization.

Primary Responsibilities and Duties:

Responsibilities:

• Responsibilities are groupings of tasks/duties, not a list of individual tasks. Generally each position has 4 to 6 responsibilities.

75%   

• Perform activity required to support /maintain controlled procedures and documents through the DMS System. Assists departments with editing and releasing controlled procedures and documents through the DMS System. 

15%   

• Maintain records, logs, e-files as assigned.

10%   

• Assist with other Quality and Transition Projects.

• May perform other duties as required

KSA Requirements (Knowledge, Skills, and Abilities):

Knowledge:

• Strong conceptual knowledge of quality management systems and industry related regulations (FDA 21 CFR 820, ISO 13485)

Skills: 

• Strong interpersonal skills, including persuasion, effective communication, objectivity, assertiveness, and thoroughness.

• Strong administrative & Transactional skills
• Experience using SAP for Document Management preferred
• Ability to review procedures for flow and grammar.
• Strong Microsoft Office Skills.
• Ability to create /modify complex formatting in MS WORD.
• Ability to create diagrams using Visio or PowerPoint preferred.

Education/Degree:   

• BA or BSc degree preferred. Relative experience will be considered in lieu of a degree

Experience:

• Minimum 2 years’ experience in Quality systems or process development.
• Medical device is preferred. Automotive and Aerospace will be considered. 6 years’ relative experience in lieu of a degree.