Sunrise Systems, Inc. · 10 hours ago
Quality Engineer 3
Franklin Lakes, NJ
Full-time
Hybrid
Mid, Senior Level
$44/hr - $46/hr
5+ years expSunrise Systems, Inc. is partnering with a leading Medical Devices Manufacturing Company to find a Quality Engineer 3. This role is responsible for supporting new product development and maintenance through Quality Engineering skills, ensuring products meet quality standards and regulatory requirements.
Information Technology & Services
No H1B
Responsibilities
Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools
Proven problem-solving skills
Makes measurable improvements to client processes and procedures
Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
Acts as a team member representing Quality on new product development and sustaining engineering projects
Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc
Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training)
May perform other duties as required
Qualification
Required
Design Controls
FDA Quality System Regulation
Proactive Problem Solving
Process Validation
Will handle projects and tasks from inception through launch and Maintenance
5 years of experience
BS
FDA, Med Device, required
Able to present to upper management
Design control, Risk, Supplier Qualifications, Input, Output, FMEA's and DOE's, SPC's, Validation
Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience
Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of Client products
Applied knowledge of Corporate and/or Unit requirement
Able to contribute to the completion of specific programs and projects
Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers
Able to revise policies and procedures
Able to make presentations
Can independently determine and develop approach to solutions
Able to provide guidance and work direction to lower level project developers
Can design and perform development working independently within defined parameters with minimal supervision required
Preferred
Experience with Client software systems utilized in the Quality Systems is desirable
Acceptance sampling theory and application
Statistical process control methods and application
Measurement system/test method knowledge and analysis
Quality planning
Failure analysis investigation
Design of Experiments
Process mapping and value stream analysis
Hypothesis testing
Descriptive statistics
Process capability analysis
Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc
Risk Management
Supplier quality management
Auditing
Design/development tools
Process validation
Software validation
Benefits
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees.
Sick time benefits as required per State regulations.
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
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