Quality R&d

**MISSION**

Support the Product Development Team in their quest to get new products to market in the most efficient and effective way. Strengthen the Quality Management System in compliance with applicable standards & regulations. Ensure products release for the market have the proper well-controlled product and process design system that ensures that new products are introduced to our product portfolio and enter the market as soon as possible and with minimum risk. Deliver knowledge of the requirements of the Quality System Regulations and the expectations of both the regulatory authorities and our customers’ needs in terms of documentary evidence of a product development process under complete control.

**KEY ACCOUNTABILITIES**
- ** Procedures and quality system**

Establish and maintain the Design and Development Procedures and Templates in compliance with the Quality System Regulations and pertinent ISO standards (ISO 15378, **ISO13485**, ISO14971, 21 CFR part 820, EU GMP’s Annex 20 and ICH Q). Control the respect of the procedures in Product Development activities and deliver the knowledge of the quality system through training sessions and continuous supporting activities to the Product Development team.
- ** Design Control Documentation and Records**

Support the Product Development team in planning the stages of product development process (Design Planning, Design inputs; design outputs; design review, design verification; design validation; risk management; change control, post market information). Participate and support the managing of the design review meetings. Review and approve the design control documentation as quality assurance representative expert of the product development process, responsible of the completeness of the documentation in conformity to the procedures in place, on the adequateness of the personnel involved respect the fields of competence and on the coherence of conclusions. Collaborate with Product Development to maintain updated the design control documentation respect the continuous improvement.
- ** Design history file**

Define the structure of the Design History File for product families and specific projects. Support Product Development team in the redaction of the technical documentation in compliance with the Design and Development Procedures System procedures. Approve the Design History File documentation as Quality Assurance representative, expert of the product development process, responsible of the completeness of the documentation in conformity to the procedures in place, on the adequateness of the personnel involved respect the fields of competence and on the coherence of the conclusions. Collaborate with Product Development to maintain aligned the design documentations with the current product realization.
- ** Change control**

Extend the change control procedures to the design and development process and the complete product lifecycle, in compliance with ISO 13485, 15378 and 21 CFR Part 820.30. Evaluate, in cooperation with Product Development team, the impact of the product and processes changes respect the product design and the related design control documentation. Evaluates the changes in term of risk assessment on the product design and participate in the approval iter of the change and the related activity plan. Collaborate with Product Development to maintain updated the design documentation respect the change control system.
- ** Production and post production information**

Establish periodic review of production and post production information, evaluate potential impact on the design and the risk assessment of the products, collaborate with Product Development team to maintain updated the design documentation.
- ** Relationship management**

Interact regularly and effectively communicates with Quality Assurance and Regulatory Affairs team in order to be a point of contact between Product Development team and Quality Assurance. Interact regularly and effectively communicates with product development team to be aligned with the development activities and projects steps. Be the internal point of reference during audits or technical visits in terms of Design Control.

**Qualifications**
- Technical or scientific background
- 5/10 years of experiences in Quality Assurance or Regulatory affairs in companies Developing Medical Device or Primary packaging for Pharmaceutical product filed.
- Quality Assurance/Design Quality/Regulatory Affairs in medical device company
- Design Control requirements and principles according 13485 and CFR21 part11 820.30
- Technical File and Design History file review
- Medical Device Design Verification and Validation
- Usability engineering according IEC 62366
- Knowledge of primary packaging regulations
- Knowledge of medical Device regulations (MDR)
- Risk analysis methods and tools according ISO 14971
- Fluent English, both written and spoken

LI-DNI

Adherence to **Stevanato Group’s Values**: Trust and respect