07 October 2021
Manufacturing Quality Engineer

Manufacturing Quality Engineer
Company Confidential
Miami- Ft Lauderdale Area 
(6 Months Project)- Must be on-site
ttg Talent Solutions has been engaged by one of his Medical Devices clients to find their next Manufacturing Quality Engineer, in the Miami Area.
We are looking for a Manufacturing Quality Engineer with strong experience on:

 EO Sterilization  and  Validation Experience required

You will design and implement test plans and audits for products to ensure product quality targets are met. Establish, define, implement, maintain, and report on quality assurance key performance measures and standards. Investigate non-conformances and consumer complaints, perform root cause analysis, implement corrective actions, and monitor progress and improvements. Drive continuous improvement through communication and training on quality standards, requirements, and best practices. Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions.
  • Develops process validation and IQ/OQ/PQ protocols, executes protocols and generates reports.
  • Lead the development of quality and operating procedures to assure alignment with current GMP/QSR, ISO and MDD requirements.
  • New Product Development and quality plans.
  • Verification of engineering tests and measurement practices for new and existing products using QA Tools.
  • Develops inspection and testing methods and participates in the preparation of quality assurance specifications and procedures to implement such methods.
  • Compliance including FDA and International regulatory requirements.
  • Quality assurance requirements: Critical to Quality Design Output Requirements.
  • Supports annual training to the requirements of QSR, CMDR, ISO 13485 and the MDD for all appropriate personnel as necessary.
  • Collaborates in ensuring adherence to requirements and closure of CAPAs
  • Oversee and manage incoming Supplier Quality. Initiate and drive Supplier Corrective Actions.
  • Facilitate Design and Process FMEA’s and oversee mitigation efforts to closure.
  • Participate in design reviews to ensure adherence to design control requirements -- review drawings for adherence to design inputs; material callouts and standards and procedures; and regulatory and QS requirements; verify that required reports are attached so that the project can proceed to the next phase.
  • Bachelor’s Degree in a scientific discipline (Engineering preferred).
  • A minimum of 5 years of experience in Quality in a regulated industry.
  • 3 or more years of experience in manufacturing plant.
  • Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations.
  • Experience developing process validation and IQ/OQ/PQ documentation.
  • Knowledge of project management and CAD (Solid Works) software.
  • Certified quality engineer (ASQ CQE) a plus
Please submit your resume in a word document format.  Please indicate your experience on your resume as it is relevant to the requirements. 
If you are a match, you will be contact by a Recruiter from ttg Talent Solutions by phone and/or email, please monitor your inbox.

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