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Engr 3, Quality

Engr 3, Quality

Pyramid Consulting, IncFranklin Lakes, NJ, United States
11 hours ago
Job type
  • Temporary
Job description

Immediate need for a talented Engr 3, Quality . This is a 12+ months contract opportunity with long-term potential and is located in Franklin Lakes, NJ (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID : 25-90752

Pay Range : $40 - $44 / hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities :

  • Consistent application of technical principles, theories, concepts, techniques, and quality sciences / tools.
  • Proven problem-solving skills.
  • Makes measurable improvements to 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.

Key Requirements and Technology Experience :

  • Key Skills; Quality Engineer
  • FMEA, Failure analysis
  • New Product Development
  • 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 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 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

    • Our client is a leading M edical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

    Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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    Quality • Franklin Lakes, NJ, United States