Software Quality Engineer

Company Name: Staffit-Now, Inc
Location: San Diego, California-92101
Max Rate: 80 $/hr - 150 $/hr
Status: Contract
To Apply Go To www.staffitnow.com and Enter job Id 656319

Description: (Visit the site for detailed description)
PRIMARY FUNCTION:
This position establishes and maintains software quality control throughout the entire software development lifecycle, including the Requirements, Design, Build and Verification phases. The position ensures that systematic, integrated design and testing employ a process that produces measurable results.

MAJOR DUTIES AND RESPONSIBILITIES:
Provides Quality oversight and signatory responsibility to Device Software Development
Ensures that an adequate system for capturing, reporting, tracking, and analyzing defects is in place and that defect metrics are recorded, monitored, and compared to organization and industry standards.
Ensures that testing is handled as an integral part of the development process, using the same systems engineering discipline as software development.
Ensure that Capability Maturity Model (CMM) Level and goals for improvement are established.
Maintains cooperative proactive relationship with departments within the site, division, and Corporate Quality Assurance

D. EXPERIENCE:
Minimum of 3 years in a software quality assurance role in a medical device or related industry in a regulated environment
Understands and implements the concepts of the Capability Maturity Model (CMM) of the Software Engineering Institute
Extensive experience using DevTrack, DOORS, TestTrack, Microsoft Office
Strong project management and leadership skills
Extensive experience and working knowledge of software requirements management, design, development, verification and validation
Strong verbal and written communications skills
Proven ability to work across geographic and functional organizations
Demonstrable experience implementing strategic and company-wide quality initiatives

E. PROBLEM SOLVING:
Ensures QA support for San Diego Research and Development activities for assigned programs including active participation on project teams and oversight to ensure compliance with regulations, site and corporate policies and procedures.
Primary member of the Cross Functional Review Team (CFRT). Participates in analysis and documents all decisions made.
Tracks, assembles and reports all project metrics.
Responsible for conducting assigned site internal audits.
Responsible for ensuring that assigned programs are compliant with US Food and Drug Administration Quality policy, Quality Guidelines and all other pertinent regulations and standards.
Analyze, document and monitor Corrective And Preventative Actions (CAPA s).
Trains program and project team members in all aspects of quality.
Responsible for assigned program/project Design and Document control.

F. ACCOUNTABILITY:
Primary quality advocate and integral team member responsible for ensuring that quality products are released in a timely manner

G. ANALYTICAL ABILITY
Conducts Root Cause Analysis of failures
Compiles and analyses program metrics determining trends and responsive actions
Develops and presents program status briefings to upper level management
Conducts Regression Analysis during software Verification

H. AUTHORITY TO ACT:
Signatory on all program/project documents relating to quality.
Responsible for ensuring that assigned programs are compliant with US Food and Drug Administration, Quality Guidelines and all other pertinent regulations and standards.
Responsible for assigned program/project Design and Document control.
Responsible for conducting assigned site internal audits.

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