Quality Assurance Specialist — Senior

As a QA Specialist, you will play a central role in shaping, maintaining and strengthening the company’s Quality Management System. You will work with other company departments, ensuring compliance to regulatory requirements, driving continuous improvement and supporting the company certification process in both EU and US markets.

Key Responsibilities

• Quality Management System (QMS) Oversight: maintain and improve company QMS in compliance with ISO 13485, MDR and FDA 21 CFR Part 820. This includes drafting documentation, managing NCs and CAPAs, overseeing change control and collaborating in the management of internal audits.
• Software validation : act as the internal lead for software validation. You will manage Software Validation Plan (SVP) for production equipment and internal software (e.g., eQMS), ensuring compliance with internal procedures and regulatory requirements (21 CFR Part 11).
• Production process supervision: support the process validations, equipment qualification and ensure that the manufacturing processes operate according to internal procedure and within the validated states.
• Sterility assurance: support the monitoring of the sterility state of the product, overseeing the production and third‑party sterilization facilities activities in routine production and validation process (ISO 11135/11137).
• Batch release & traceability: oversee the batch release process and review of the batch production documents, ensuring device traceability from raw material to final product.
• Certification bodies relationships: support relationships with Notified Bodies and collaborate in the management of external audits.

Required Skills & Qualifications

Mandatory Requirements (Must Have)

• Education: master’s degree in Biomedical Engineering, Biotechnology, Biology, Pharmacy or related scientific field.
• Work Experience: 3+ years of experience in Quality Assurance within the Medical Device or Pharma industry.
• Regulatory Experience: deep knowledge of FDA 21 CFR 820, ISO 13485, and EU MDR; deep knowledge of GMP is a plus.
• Technical Expertise: previous experience with a strong focus on supporting production activities, including in process and quality control tests, hands‑on experience in managing and reviewing production‑related quality documentation, on software validation management and previous experience with the transition between a non-electronic quality management system and a eQMS; direct experience with 21 CFR Part 11 compliance is a plus.
• Communication: professional fluency in English (written and spoken) and the ability to influence cross‑functional teams.
• IT: excellent knowledge of MS Office (Word and Excel).
• Soft skills: excellent organizational skills, goal‑oriented mindset and attention‑to‑details attitude.

Preferred Requirements (Nice to have)

• Previous experience in GMP company(ies).
• Previous experience with biodegradable implantable medical devices.
• Previous experience with the batch release process.
• Familiarity with ISO 11137 sterilization standards.Familiarity with data integrity principles (ALCOA+).
• Previous experience with Asana software or other work management platforms.
• Third‑party auditor 13485 certificate.

What We Offer & Recruitment Process

The company offers a structured onboarding program, including a two‑month period of induction, training, and close mentoring to support the successful integration of the selected candidate. Depending on the candidate’s profile and assessment, the company offers either an apprenticeship contract or a permanent employment contract, with a starting gross annual salary (RAL) of € 35,000 under the Chemical Industry SME collective agreement (CCNL Chimico Confapi) which will be adjusted based on the candidate’s knowledge and experience. The compensation package also includes:

• annual company’s performance bonus of € 2,300 gross
• a € 1,000 annual welfare allowance
• € 8 meal vouchers for each working day
• hybrid work policy with one day of remote work per week
• accident and supplementary health insurance coverage

In accordance with current regulations, this position is open to candidates of all genders, without any form of discrimination.