Quality Production Operations

Purpose

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:
  • 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

Qualification – Required Knowledge, Skills and Abilities

• Knowledge of 2017/745(MDR) and 21 CFR 820
• Knowledge of 13485: 2021
• Skills:
  • Strong technical troubleshooting and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Good English Level (writing and speaking)
• Personal Attributes:
  • 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 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%