Quality Engineer 3

Our client, a leading Medical Devices Manufacturing Company is looking for Quality Engineer 3 and This is for an initial duration of 12 Months Contract — Franklin Lakes, NJJob Title: Quality Engineer 3
Job Id: 25-11395
Location: Franklin Lakes, NJ
Duration: 12 Months Contract
Position Type: Hourly Contract Position (W2 only)

• Hybrid 4 days a week in office
• Travel domestic

Must Have

• 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
• Urgent need starts date mid-November.

Role

• The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices.
• This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• 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.

Education and Experience:

• 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.

Knowledge and Skills:

• 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.
• 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

Compensation: The hourly rate for this position is between $44.00-$46.00 per hour.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.Qualified candidates please send your word format updated resume at the earliest to Pavan: [732-395-4444] OR Sangeeth: [732-395-4555]Thank You.

Sunrise Systems