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.
Work Location: Rome – Italy – Viale Ostiense 131/L
Key Responsibilities
* Production Support:
o Oversee all processes related to the collection and review of the production records.
o Review the Device History Records related to medical device products and ensure the correctly storage of records
o Support the Medical Device Production Manager in the planning of the production process
o 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
Qualification – Required Knowledge, Skills and Abilities
* Knowledge of 2017/745(MDR) and 21 CFR 820
* Knowledge of 13485: 2021
* Skills:
o Strong technical troubleshooting and problem-solving skills.
o Excellent communication and collaboration abilities.
o Good English Level (writing and speaking)
* Personal Attributes:
o Ability to work independently and collaboratively across multifunctional teams.
o Resilient and able to work effectively under stress and tight deadlines.
o Willingness to travel as needed.
Minimum Required Education and Experience
* Experience: 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
* Education: Bachelor’s degree in engineering, or a related field.
Physical Requirements
* Expected travel is 20%
Apply
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