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Quality Production Operations

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Cosmo Intelligent Medical Devices

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Location:
Italy , Rome

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Join the Quality Production Operations team to drive excellence in manufacturing and ensure the highest standards of quality and compliance in the production of advanced medical devices.

Job Responsibility:

  • Oversee all processes related to the collection and review of the production records
  • Review the Device History Records related to medical device products and ensure the correctly storage of records
  • Support the Medical Device Production Manager in the planning of the production process
  • Ensure that all production activities comply with regulatory standards, quality control protocols, and company policies
  • Incoming Inspection: support the R&D ensure that the procedure for deciding when the lot under inspection is to be rejected or accepted
  • Equipment Management: manage the equipment calibration and archive the records
  • Non conformities management: open and manage the non conformities issued during the production process, correction and corrective action
  • Problem Solving: support the Medical Device Production Manager in the implementation of the corrective actions to minimize disruptions and maintain continuous production flow. Ensure that activities are correctly carried out and registered
  • Supplier Management: perform the supplier qualification and supplier monitoring process and support the Quality Assurance Manager during the audit at the supplier
  • Training: ensure that the training and guidance to production staff are correctly registered
  • Design transfer: ensure that the design transfer activities are correctly carried out and registered
  • Compliance: Support the Regulatory Affairs in the compliance with all relevant regulations, including FDA, ISO, and other international standards
  • Internal Audit: Support the Quality Assurance Manager in the production process’s evaluation in compliance with all relevant regulations, including FDA, ISO, and other international standards

Requirements:

  • Knowledge of 2017/745(MDR) and 21 CFR 820
  • Knowledge of 13485: 2021
  • Strong technical troubleshooting and problem-solving skills
  • Excellent communication and collaboration abilities
  • Good English Level (writing and speaking)
  • Ability to work independently and collaboratively across multifunctional teams
  • Resilient and able to work effectively under stress and tight deadlines
  • Willingness to travel as needed
  • Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on production processes
  • Bachelor’s degree in engineering, or a related field

Additional Information:

Job Posted:
December 07, 2025

Work Type:
On-site work
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