Sunrise Systems, Inc. · 9 hours ago
Quality Engineer 3 - Medical Device
Franklin Lakes, NJ
Contract
Hybrid
Senior Level
5+ years expSunrise Systems, Inc. is seeking a Quality Engineer to support new product development and maintenance for medical devices. The role involves managing projects from inception to launch while ensuring compliance with quality standards and regulatory requirements.
Information Technology & Services
Hiring Manager
Ashwini M
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
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
Must have knowledge/specialization in one or more of the following areas: 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
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
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase