Manufacturing Validation Specialist

1 week ago


Shelton, Connecticut, United States SysMind Tech Full time
Job Description

Job Title: Manufacturing Validation Engineer

Job Summary:

We are seeking a highly skilled Manufacturing Validation Engineer to join our team at SysMind Tech. As a key member of our quality assurance team, you will be responsible for ensuring the quality and reliability of our medical devices.

Key Responsibilities:

  • Support medical device manufacturing processes and ensure compliance with regulatory requirements.
  • Develop and implement process validation plans, including process characterization, equipment IQ/OQ, process OQ, and PQ validation.
  • Lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
  • Collaborate with cross-functional teams to identify and resolve technical and process issues.
  • Develop and maintain quality control procedures, including change management, nonconformance reports, and corrective and preventive action.

Requirements:

  • Experience in medical device manufacturing and validation.
  • Strong knowledge of design control and cGMP requirements for medical device manufacturing.
  • Ability to read and understand engineering drawings.
  • Proficiency in statistical process control concepts, process development, and CNC programming terminology.
  • Excellent communication and problem-solving skills.

What We Offer:

At SysMind Tech, we offer a dynamic and challenging work environment, competitive compensation, and opportunities for professional growth and development.



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