Quality Assurance Specialist — Junior

As a QA Specialist, you will collaborate 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 Oversight: contribute to maintain and improve company QMS in compliance with ISO *, MDR and FDA 21 CFR Part 820.
Document control: draft and update operating procedures and work instructions related to quality management processes.
Control of records generated during company processes.
Change control: assist other company teams in change management.
Nonconformities management: support the management of nonconformity (NC), root cause analysis (RCA) and corrective and preventive actions (CAPA).
Audits: assists in conducting internal audits.
Training: collaborate on educational activities of Tensive's personnel.
Production process supervision: observe the production process and collaborate in the validation of the manufacturing steps, including software applied, with the goal to minimize errors and products' defects or non-conformities.
Suppliers: participate in the evaluation, selection, monitoring, and re-evaluation of suppliers.
Certification bodies relationships: support relationships with Notified Bodies and collaborate in the management of external audits.
Required Skills & QualificationsWe are looking for self-motivated individuals who are eager to learn and driven to build a career in Quality Assurance.
Our team invests heavily in coaching new hires.
Mandatory Requirements (Must Have)

Education:
master's degree in Engineering, Biotechnology, Biology, Pharmacy or related scientific field.
Regulatory

Experience:
knowledge of ISO * standard.
Communication: professional fluency in English (written and spoken) and the ability to effectively collaborate with cross-functional teams.
IT: excellent knowledge of MS Office (Word and Excel).
Soft

skills:
excellent organizational skills, goal-oriented mindset, attention to detail attitude, attitude to teamwork and ability to work in a small, fast-growing startup environment.
Preferred Requirements (Nice to have)Previous experience within the area of Quality Assurance, preferably in the medical device industry.
Previous experience with biodegradable implantable medical devices.
Knowledge of FDA 21 CFR 820, EU MDR and GMP.
Knowledge of risk management processes (ISO *).
Familiarity with data integrity principles (ALCOA+).
Previous experience with Asana software or other work management platforms.
Benefits & CompensationStructured onboarding program: two months of induction, training, and close mentoring to support successful integration.
Starting gross annual salary (RAL) of €26,000 under the Chemical Industry SME collective agreement (CCNL Chimico Confapi), adjusted based on the candidate's knowledge and experience.
Annual company performance bonus of €2,300 gross.
€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.
EEO: open to candidates of all genders, without any form of discrimination.
Position ID: J-*-LjbffrQuality Assurance Specialist — Junior
- Rome, Italy#J-*-Ljbffr