Software/Hardware Quality Engineer

Job Title – HW/SW Quality Engineer
 
Job Location – Bothell WA
 
Length – Contract (4-5 Months+)
 
You are responsible for

 •Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design with an emphasis on software validation and design controls.
 •Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
 •Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle with an emphasis on software.
 •Performs independent technical assessment on product quality performance and post-market product quality analysis
 •Can Lead quality related problem solving and root cause analysis during design and manufacturing
 •Act as a single point of contact (person assigned to project team) responsible to ensure that software based design meets quality and compliance standards for every milestone
 •Function as a local subject matter expert on software validation techniques and management of electronic records and signatures.
 •Provide leadership and oversight to ensure Quality Management System Compliance
 
 You are a part of
 
 Emergency Care and Resuscitation is a key business along the continuum of care, and has a broad product portfolio of advanced life support solutions, automated external defibrillators, and data management solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers – from clinicians to paramedics, first responders to the ordinary person – to save lives using our innovative, market leading technology. We are searching for passionate leaders to join us as we strengthen our product portfolio, expand our services and solutions, and bring game changing technology to market.
 
 To succeed in this role, you should have the following skills and experience
 
 •Engineering Degree or equivalent experience in medical device industry. 
 •5+ years’ experience with a medical device company 
 •ASQ certified Quality Engineer 
 •Working knowledge of C#, Java, Python, or other managed programming language. 
 •Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics. 
 •Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements. 
 •Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving. 
 •Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems 
 •Multiple years of experience working in a software design and quality assurance environment 
 •Demonstrable experience validating software in a manufacturing environment.
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com
609-357-9180 (Direct)

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file