Sunrise Systems, Inc.
Quality Engineer - Medical Devices
8 days ago
Franklin Lakes
Contract Duration: 12 Months contract (W2 only) Location : Franklin Lakes, NJ (locals only) • Hybrid 4 days a week in office, • The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices., • 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)., • 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., • 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 Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate]. Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.