SeniorQuality Engineer

Overview

On Site
$60 - $65
Contract - W2
Contract - 06 Month(s)

Skills

experience in the development
deployment of Quality Systems
experience related to Quality
FDA
Medical Device industry.
FDA cGMP
ANSI
ISO
ASQC

Job Details

Immediate need for a talented Senior Quality Engineer. This is a 06+months contract opportunity with long-term potential and is located in Medina, NY (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-75496

Pay Range: $60 - $65/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:

  • Lead and execute complex validations, including IQ, OQ, PQ, and MSA protocols and reports for processes, equipment, test methods, and computerized systems within the facility.
  • Drive and provide guidance for change control processes, ensuring alignment with procedural and regulatory requirements.
  • Act as the primary representative during external audits, presenting, defending, and communicating effectively on validation projects or quality-related initiatives.
  • Lead process improvement projects with a focus on efficiency and effectiveness across operations, including scrap reduction and defect reduction.
  • Collaborate effectively with cross-functional teams, including production, quality, laboratory, and service, driving alignment on quality initiatives.
  • Demonstrate advanced technical expertise in engineering principles and procedures, utilizing tools such as CAD and specialized software in areas like chemical, industrial, or biological engineering.
  • Lead technical reviews, organize data, and prepare comprehensive documentation for complex projects.
  • Mentor junior level engineers and provide technical support during design, installation, qualification, and ongoing process monitoring.
  • Develop and deliver data-driven technical reports and analyses to support continuous improvement initiatives.
  • Drive strategic plant initiatives related to new process/technology development and implementation.
  • Perform other duties as assigned
  • PHYSICAL DEMANDS
  • Able to exert up to 10 pounds of force occasionally.
  • Able to sit, stand, walk throughout the workday.
  • Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The client is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.
  • Wearing a protective smock at all times while in the manufacturing work area
  • Working in close proximity to other employees.
  • Working in an environment that is temperature and humidity controlled.

Key Requirements and Technology Experience:

  • Key Skills; Bachelor s degree in engineering is required.
  • 3-5 years of engineering experience related to Quality, preferably in an FDA regulated environment/Medical Device industry.
  • Proven experience in the development and deployment of Quality Systems
  • To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.
  • Medical Device Experience with knowledge of 21CFR820 preferred.
  • Investigational research skills
  • Experience with any statistical software packages (Minitab a plus)
  • Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS preferred.
  • Knowledge and working application of reading and understanding blueprints and technical drawings.
  • Knowledge of process improvement methodologies such as Lean Six Sigma.
  • Strong communication skills with the ability to engage in complex technical and project management issues, both verbally and in writing.
  • Ability to manage multiple projects simultaneously, prioritize effectively and meet tight deadlines.
  • Demonstrated strong analytical problem solving (Root Cause Investigations)
  • Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools).
  • Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
  • Ability to multi-task and methodically manage projects.

Our client is a leading Healthcare 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.

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