Quality Production Operations Jobs

Cosmo Intelligent Medical Devices

Location:
Italy, Rome

Category:
Manufacturing

Contract Type:
Not provided

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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