Senior Quality Assurance Engineer
19 hours ago
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at MillenniumSoft. As a Senior Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and services, and for developing and implementing quality assurance processes and procedures.
Key Responsibilities:
Provide quality engineering representation on various project teams supporting product remediation
Initiate new or revised documentation
Develop and implement quality assurance processes and procedures
Conduct and/or coordinate testing outlined in protocols and test methods
Perform process improvement, control and monitoring on manufacturing processes
Provide technical direction during design transfer activities
Participate and provide input to training on department/division procedures, and policies
Develop and implement procedures to comply with corporate and industry standards
Understand and follow company procedures on regulatory requirements
Provide support to the regulatory department in writing technical submissions
Maintain a professional working relationship with internal and external customers and support staff
Prepare and present project updates and technical discussions
Requirements:
BS in Electrical Engineering (EE) or Computer Science/Systems (CS) or Software Engineering (SE) strongly preferred, or
BS in Engineering (Biomedical, Mechanical, Materials, Chemical), ideally with practical work experience in electrical or software technologies
Minimum of 3 years' experience with either New Product Development OR Sustaining Products
Strong experience with developing/creating design input requirements (DIRs) and risk management documentation (Design FMEAs) is a PLUS
Medical Device experience is strongly preferred, but not required
Quality Engineering experience desirable, but not mandatory
Ability to make and present engineering decisions
Able to perform PCB/system level design reviews or PCB testing
Demonstrated Project Management skills
Understanding and application of DOE
Ability to analyze and optimize manufacturing and quality systems
Advanced product, design & prototyping skills and perform design review functions
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
In-depth knowledge of regulatory requirements
Ability to develop and control a budget and understand engineering cost analysis
Advanced statistics and software application skills
Advanced problem-solving skills
Ability to create/provide training, manage technical personnel and lead cross-functional teams
Strong interpersonal skills and must read, write, speak and understand English
Must be detailed in handling information/data and have excellent oral and written presentation skills
What We Offer:
MillenniumSoft offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Quality Assurance Engineer looking for a new challenge, please submit your application.
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