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Quality Assurance Specialist

2 months ago

South Plainfield, New Jersey, United States Katalyst Healthcares & Life Sciences Full time
Quality Management Specialist

Katalyst Healthcares & Life Sciences is seeking a seasoned Quality Management Specialist to join our team. As a key member of our Engineering department, you will be responsible for developing and implementing Quality Management Systems (QMS) that meet the highest industry standards.

Responsibilities:
  • Develop and maintain QMS and overall Product Quality Methodology, including product development processes, tools, and quality assurance.
  • Design and implement a Quality Documentation Approach, identifying needs and gaps in SOPs, policies, forms, and templates.
  • Support existing team members with training, reviewing processes, documents, and capabilities, and recommending improvements and optimizations.
  • Ensure ISO 9001 readiness and capability.
Requirements:
  • Bachelor's Degree in a relevant field with 10+ years of industry experience.
  • Strong medical device or diagnostic lab equipment experience, with a blend of medical device and pharma experience acceptable.
  • Prior experience conducting QMS implementations and auditing experience with ISO 9001.
  • Engineering background and strong understanding of QMS-related documentation and training development.