Product Expert
hace 2 días
Location- El Prat de Llobregat- Type of contract- Permanent
Full Time- Occupational field- Medicine & Healthcare- Job-ID- 11851- Job SummaryEvaluates complex medical devices with medium risk and the according documentation.
- Job Description- Evaluates complex medical products according to the relevant technical regulations and relevant EC directives, including documentation that conforms to standards.
- Reviews the technical documentation / design dossiers of medical devices with medium risk.
- Conducts Evaluations in several special areas depending on the product group and degree of authorization:
- Sterilization and its validation
- Preparation of medical products
- Packaging and its validation
- Clean room qualification and monitoring
- Product and personal hygiene
- Evaluation of biotechnology-based production processes, software
- Radiation
- Conducts evaluation of fundamental aspects that play a role in the context of product-related evaluations.
- Creates a compliant documentation.
- Acts as Certifier and / or specialist certifier if required.
- And other duties as assigned.
LI-ES
- Experience & Further Qualifications- Degree in a technical, scientific or engineering field.
- At least 2 years professional experience in development, production, quality assurance, regulatory affairs or quality management of medical devices (related to IVD area);
- Four years of professional experience is a plus.
- Auditor training is a plus to ISO 13485 or ISO 9001.
- Knowledge of relevant guidelines, norms, and product specific standards;
- Fluent in Spanish and English, Portuguese is a plus.
- Local and international business trips are required (depending on job position focus as Auditor and/or Product Expert 20 to 35% per month).
- We can we offert to you?- Hybrid mode of work 70% office - 30% remote.
- Stable job with permanent contract.
- Employee training and development.
- Negotiable salary package.
- International environment and daily use of foreign languages.
- Flexible compensation package: meal card, transportation card, company health insurance policy and childcare vouchers.
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