Sofware Quality Engineer

Purpose: ~ LOCAL CANDIDATES PREFERRED. ~ This is a direct placement positions available - you choose the workstyle that suits your lifestyle

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Sofware Quality Engineer
Location:US-CA-San DiegoJob Category:Engineering

Purpose:
~ LOCAL CANDIDATES PREFERRED. ~

This is a direct placement position in the Carmel Valley section of San Diego.

SUMMARY:
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.

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

EDUCATIONAL BACKGROUND:
Bachelors degree and formal education required in Software Quality Assurance and Software Quality Engineering principals and practices.

EXPERIENCE:
- Minimum of 8 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

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 (21 CFR part 820).
- 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.

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

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

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 (21 CFR part 820).
- Responsible for assigned program/project Design and Document control.
- Responsible for conducting assigned site internal audits.

Classification:
Direct Placement

Compensation:
DOE Year

Join Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek CE offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek CE team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
DOORS, DEVTRACK, TESTTRACKContact Information
Contact:Farren,Daniel J