Medical Device QA Inspector for Quality & Compliance

Katalyst CRO

Sandy (UT)

On-site

USD 52,000 - 76,000

Full time

8 days ago

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Job summary

Katalyst CRO is seeking a quality role to support production in a medical device environment. The position involves gowning, PPE, and extensive walking/standing, with a focus on detecting visual defects and ensuring quality compliance.

Responsibilities include training staff, conducting audits, maintaining documentation, and driving continuous improvement across inspection processes and safety practices.

Responsibilities

  • Provide training and feedback to operations staff to support skill development and compliance with quality standards.
  • Promote a culture of quality, safety, and continuous improvement within the team.
  • Monitor inspection processes and ensure adherence to SOPs, work instructions, and quality standards.
  • Conduct daily audits of production areas and documentation to ensure compliance and identify improvement opportunities.
  • Maintain accurate and timely documentation of inspections, audits, and quality events.
  • Support preparation for internal and external audits.
  • Identify and recommend improvements to inspection methods, tools, and documentation practices.
  • Assist in containment and segregation of nonconforming product/materials with proper documentation and escalation.
  • Confirm defects of nonconforming product/materials found in production.
  • Assist in root cause investigations and corrective action implementation for deviations and nonconformances.
  • Collaborate with operations and engineering to resolve quality issues and improve inspection processes.
  • Communicate effectively with cross-functional teams to support production goals and quality initiatives.
  • Participate in quality improvement projects.
  • Ensure compliance with safety regulations, including hazardous waste handling, and company policies.
  • Perform other duties as assigned.

Job description

Katalyst CRO is seeking a quality role to support production in a medical device environment. The position involves gowning, PPE, and extensive walking/standing, with a focus on detecting visual defects and ensuring quality compliance.

Responsibilities include training staff, conducting audits, maintaining documentation, and driving continuous improvement across inspection processes and safety practices.

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