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Quality Engineer, Project Manager, Software, Medical Device

Company: GForce Life Sciences
Location: Akron
Posted on: January 15, 2022

Job Description:

Our client, a large medical device company is looking for a Quality Engineer to join their quality team. The consultant will be tasked with assisting the team to meet quality and regulatory requirements as well as meeting the design specifications and requirements for each software application. This position will also be responsible for the improvement and management of the Software Development Life Cycle.

Duties / Expectations of Role
Assist team to ensure the quality of software and adherence to design requirements and specifications prior to release
Assist in defining the test approach and scope for assigned projects implementing proven quality best practices
Assist with the traceability and risk analysis for each component
Assist in the development and maintenance of accurate and thorough test plans and test cases conducting reviews as needed
Work alongside the development teams to ensure continual unit and integration testing improvements and enhancements
Peer review test plans and test cases verifying accuracy and sufficient coverage
Identify, mitigate, and drive product issues and risks to resolution
Identify opportunities for process, tools and test methodology improvements and drive those from concept to implementation
Assist to create realistic Quality Control level of effort estimates for project planning
Effectively collaborate with Software Engineers to define user needs and acceptance criteria, and deliverables
Assist in analyzing user needs, requirements & design specifications and validate their testability
Identify areas for improvements, implement process improvements and ensure long term compliance
Enforce all Quality Assurance Processes and Procedures
Meet deadlines for assigned tasks and scheduled deliverables

Mandatory Requirements
B.S. in engineering or computer science or equivalent
1-2 years of experience within a medical device organization
Strong communication, organizational and presentation skills
Strong work ethic, self-directed, and resourceful with the ability to deal with conflict and drive to solution
Proven ability to lead, influence and work well at all levels of an organization and in a cross functional team environment
Ability to handle ambiguity effectively and oversee multiple projects at once
Demonstrated ability to synthesize data, set actionable goals and drive metrics and execution
High attention to detail and proven ability to manage multiple, competing priorities simultaneously; must work well under pressure, be flexible, and meet deadlines
Energetic and balanced person with a drive for results, who feels accountable, has a great attitude, and is a team-player; self-starter with high degree of initiative, urgency, and follow through

Nice to Have Requirements
Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred
Experience in a software development, validation, or quality role, or an equivalent combination of education and experience.
Knowledge of the following: IEC 62443-cybersecurity, FDA 21CFR820, ISO 13485:2012, ISO 14971, ISO 62304
Knowledge of the different types of testing such as White/Black-box, unit, functional, regression, integration, performance and acceptance
Understanding of validations and testing methodology and software development lifecycle
Internal Auditing Experience for Quality System Regulations (ISO 13485, MDSAP, Quality System Regulation 21 CFR Part 820, etc.)
Certification in project management (PMP)
Experience in quality systems, quality engineering, or compliance in the medical device or other regulated industry

Term & Start
3-6+ month engagement, start immediately
Onsite in Cleveland Area
Could potentially lead to a full-time position
Medical benefits available (medical, dental, vision)

Keywords: GForce Life Sciences, Akron , Quality Engineer, Project Manager, Software, Medical Device, IT / Software / Systems , Akron, Ohio

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