Quality Engineer II

Position: Quality Engineer II

Location: Tempe, AZ

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Mid-Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Essential Job Functions:
• Provide Quality Engineering representation on various project teams supporting product remediation
• Initiate new or revised documentation
• Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
• Lead cross-functional teams to develop risk assessment
• Develop physical and functional test methods to ensure specifications are met
• Write, review and approve design verification and validation protocols and reports
• Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications
• 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 provides 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
• Provide positive example and actively promotes compliance to all standards
• Maintain a professional working relationship with internal and external customer and support staff
• Prepare and present project updates and technical discussions
• Familiar with the latest editions of standards IEC 60601 Series (especially 60601-1 and 60601-1-2), IEC 62304, IEC 62366 & ISO 14971
• Familiar with sampling standards like ANSI/ASQ Z1.4, ISO 2859-1 and ANSI/ASQ Z1.9
• Familiar with reliability references like MIL-HDBK-217F, MIL-HDBK-344A and MIL-HDBK-781A is a plus
• Ability to work together with others in a team environment, using data and soft skills to navigate towards solutions

Basic Skills/Competencies Required:
• Must have a 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

Additional Skills:
• 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

Education required:
• 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