**Make a Difference with Quality Assurance**
Are you looking for a business where your efforts and activities are recognized, and you can contribute to and develop the company?
**Quality Assurance Associate**
**Industry:** Pharmaceuticals and Medical Devices
**Employment Type:** Full-time
**Seniority Level:** 2-4 years experience
**Location:** Milan (Italy) – Home based smart working
**Job Description:
* Manage Italian subsidiary quality systems primarily in accordance with ISO 13485 – MDR regulation (Medical Devices) and cGDPs (Pharma).
* Manage product certification process with Notified Body.
* Handle deviations and non-conformities detected, ensuring quality of product output and verifying effectiveness of corrective actions taken.
* Handle customer complaints with related investigation, corrective activities, response, and closure complaints.
* Coordinate changes with external manufacturing.
* Maintain local training compliance (ISO, GDP, and MDR).
* Lead and participate in internal audits, organize site Management Review, track, and report KPIs.
* Support supplier/outsourced activities qualification processes audits.
* Develop Annual Product Quality Reviews and support product returns or recalls.
* Support Corporate Quality activities.
* Support all other functions within operations team where required: Operations, Sales, Marketing, Regulatory Affairs, Quality, Device/Pharmacovigilance.
**Experience Required:**
* Bachelor's degree in Life Science or equivalent.
* Ability to work flexibly and autonomously.
* At least 2-4 years experience in Regulatory Affairs and Quality Assurance for medical devices.
* Proven knowledge in ISO 13485, ISO 19011, MDR 2017/745, and IT/EU cGMPs.
* Self-confidence and ability to work with all levels of organization.
* Operates in a way that never compromises ethics or integrity.
* Fluent English.
**What We Offer:**
* An exciting opportunity in a fast-growing international medical device and pharma company.
* A modern working environment with multicultural and dynamic teams.
* Flexible working hours and a hybrid smart work policy.
**Line Reporting:** Corporate Quality Director