Quality Assurance Specialist
1 month ago
Millenniumsoft is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.
Key Responsibilities:- Provide quality engineering representation on various project teams
- Initiate new or revised documentation
- Develop and validate test methods, equipment qualifications, and process validation requirements
- Lead cross-functional teams to develop risk assessments and design verification and validation protocols
- Conduct and 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 in 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
- Minimum of 3 years' experience with either New Product Development or Sustaining Products
- Strong experience with developing/designing 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
- 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
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