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FP&A Analyst
CRH
Overland Park, KS
…our customers. We manufacture and supply high-performance, advanced cementitious materials for the most demanding construction and infrastructure needs. With more than 2,000 people across…
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Leadership Development Designer & Facilitator (Manufacturing)
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…optimize content and delivery. Support the Leadership Development Program Manager in reporting on overall program effectiveness and…
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Branch Manager
Supply Technologies
Dublin, VA
…expertise in nearly every inventory management discipline; use of advanced and emerging technologies, and a singularly connected global infrastructure, only Supply Technologies has the…
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Senior Materials Engineer
Westinghouse Electric Company, LLC
Hopkins, SC
As a Senior Materials Engineer you will support development and modelling of advanced materials/manufacturing processes and conduct chemistry evaluations.
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Account Manager SMB-Business Sales- Fishers, IN
Military Spouse Jobs & VetJobs
United States
…commission. Planning to go above and beyond? Our commission program allows unlimited opportunity which could allow top earners to exceed compensation plans and compete for various sales…
Added 1 min ago
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Account Manager SMB-Business Sales- Redlands, CA
Military Spouse Jobs & VetJobs
United States
- $37,000 to $64,000 USD / year
…commission. Planning to go above and beyond? Our commission program allows unlimited opportunity which could allow top earners to exceed compensation plans and compete for various sales…
Added 1 min ago
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Account Manager SMB-Business Sales- Corona, CA
Military Spouse Jobs & VetJobs
United States
- $37,000 to $64,000 USD / year
…commission. Planning to go above and beyond? Our commission program allows unlimited opportunity which could allow top earners to exceed compensation plans and compete for various sales…
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Account Manager SMB-Business Sales- Tucson, AZ
Military Spouse Jobs & VetJobs
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…commission. Planning to go above and beyond? Our commission program allows unlimited opportunity which could allow top earners to exceed compensation plans and compete for various sales…
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Relationship Banker Business Specialist
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…encourage candidates to connect with their recruiter and hiring manager to understand workplace expectations and ensure the role aligns with their…
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Director Complaint Process Operation and Investigations
Medline Industries, LP
Mundelein, IL
- $177,000 to $266,000 USD / year
An advanced degree in a relevant scientific, engineering, healthcare, regulatory, or business discipline and experience
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Director - AI Product Manager - AI Controls & Observability
Edward Jones
United States
The Director, AI Product Manager – AI Controls & Observability is responsible for driving the end‑to‑end development and delivery of AI platform capabilities to support safe, scalable, and…
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Senior Configuration & Data Manager
Modern Technology Solutions Inc
Dayton, OH · Dayton
MTSI is seeking an experienced Configuration & Data Manager to support aircraft modernization and sustainment programs at WPAFB. In this role, you will ensure the integrity and control of…
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Account Manager - Corporate Sales
AO Swag
Coppell, TX
We are seeking a results-driven Account Manager – Corporate Sales to join the AO Swag team.
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Pharmacy Technician / Pharm Tech Apprenticeship
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- $17 to $23.25 USD / hour
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Pharmacy Technician / Pharm Tech Apprenticeship
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Pharmacy Technician / Pharm Tech Apprenticeship
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OLSA Resources, Inc.

Project Manager - 30338

CA-Alameda, CA, United States

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Job details

Posting language: English
Posted: Oct 25, 2011

Original job description

Job Description

Primary Function / Primary Goals / Objectives:

Coordinate Software QA activities in support of a new product launch or an upgrade to an existing product. Estimate, plan and review own and other's work product. Document and maintain archives for all Software product related quality activities such as plans, schedules, meeting minutes, management reviews, and departmental reviews. Prepare status reports and present to Quality Management. Ensure that computerized systmes used in support of the Quality System are developed, validated and maintained in compliance with regulatory, divisional and corporate requirements.

Major Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system. Strategic

Develop Software QA requirements and programs to meet strategic needs of the business.
Communicate software QA project status to development teams and Quality management.
Balance product cost, performance, software quality and time to market issues in order to meet ADC goals.
Coordinate activities between SWQA and operational and product development organizations from project initiation through launch. Tactical
Drive all Software QA activities associated with external development partner or internal development team.
Participate in regular project review meetings to coordinate and document the Software QA activities with associated departments contributing to a timely product launch, including QA/RA, Marketing, Operations, and R&D.
Generate and control various documentation as appropriate, such as Software QA plans, protocols, reports, resources assignments, etc.
Develop SWQA project costing estimates working with R&D, Operations, and Finance.
Provide input to the Quality process.
Manage Software QA costs on a project.
Assist SWQA team members in meeting their goals by providing coaching and mentoring as needed
Recruit, train and evaluate performance of personnel.

This position is responsible for team integration on a project for SWQA team performance, and for evaluation and reporting project status to Quality management.

Qualifications

Minimum Education Required:

Typically, the incumbent would have a minimum of a bachelor’s degree in a technical discipline. An advanced degree in either technical business field is desired. This educational background would prepare the individual for directing technical activities in a manner consistent with business drivers and both short and long term business strategies

Minimum Experience/Training Required:

Knowledge of Program Management tools such as project scheduling, work breakdown structures, time and cost reporting, is desired. Experience in both development and manufacturing of medical products for retail or hospital distribution is desired. This position requires the ability to collect information from multiple sources, sort through, integrate, and resolve often conflicting requirements, and drive an organization through the varioussoftware QA issues to result in a successful and timely software product launch. Project management with software development with increasing demonstrated responsibility and success. Experience leading and participating in technical cross-functional projects. Strong problem-solving, communications and facilitation skills. Prior experiences in medical device and/or in-vitro diagnostic industry required. Expect candidate to proactively identify and resolve resource conflicts and set priorities of parallel projects. Experience with both internally and externally developed life-science software products. Demonstrated success from initial concept to final release (full software life cycle). Knowledge of and experience with modern software testing best practices, methodologies, and techniques, particularly in testing medical devices. 10 years experience with firm knowledge of QSR/ISO/MDD/IVDD quality systems requirement, especially as they relate to software validation. In particular, has knowledge of design control requirements. Knowledge of and experience with modern operating systems (Windows), Internet technologies, object-oriented languages (e.g. C++ and/or Java), software components and instrumentation.

Accountability / Scope:

This position is highly visible and accountable, responsible for directing, and reporting to Quality management, the Software Quality Assurance activities in the launch of product and non-product applications. This position will provide leadership to project teams, integrating SWQA activities across all departments, with influence across departmental lines. Will estimate, plan and prioritize resources for multiple projects to deliver quality designs on schedule. Failure to properly validate systems may result in recalls, product deficiencies and/or disruption to business. Additional Information

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More about this job

Skills

Quality assurance procedures
Regulatory compliance
Documentation
Coaching
Reporting
Program management
Scheduling
Medical devices
Project management
Software development
Problem solving
Test medical devices
Quality control systems
Microsoft Windows
C++
Oracle Java
Quality assurance
Leadership

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