Quality Manager

Hantech Medical (www.hantechmedical.com) is specialized in Contract R&D and Manufacturing services of medical consumables and innovation of medical core components.

Our products range from interventional catheters and related consumables, infusion and drug delivery system consumables, dental consumables, diabetes treatment consumables and epidemic prevention products.

For our site in Villamarzana (Rovigo), Hantech Medical ITALY, we are looking for:

QUALITY MANAGER

Main Responsibilities:

The Quality Manager is responsible for ensuring Quality Assurance and Regulatory Affairs activities for Hantech Medical Italy organization, in accordance with applicable standards and regulations, not limited to EU legislation (i.e. FDA requirements for US).

Duties / Accountabilities:

Quality Manager leads the Quality Operations and Regulatory Affairs departments:

- Defining and overseeing the processes included in the Quality Management System (QMS) and relevant procedures;
- Monitoring the application of these processes throughout the Organization, reviewing performance of the QMS at planned intervals to ensure effectiveness and its compliance with the applicable requirements;
- Organizing the Management Review at documented planned intervals, collect the input for the review and document the output of the review;
- Managing the suppliers' qualification processes and monitoring, including the conduction of supplier audit according to the internal procedures;
- Defining adequate Quality Plan to manage the scope extension of QMS (e.g. manufacturing of products different from medical devices, plastic material transformation, etc...) and to manage the compliance to additional applicable standards;

specially for Regulatory Affairs Manager:

- Providing support to internal stakeholders and corporate Regulatory function, including product development teams, to ensure that regulatory requirements are incorporated into the development process;
- Maintaining liaises with Notified Body and regulatory authorities;
- Quality and Regulatory Manager acts as Management Representative, ensuring: the processes needed for the QMS are documented; the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization; the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released;
- In the case of investigational devices, the signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements (point 4.1 of Annex XV of MDR), is issued.

Education and working experience:

- Bachelor's degree in a scientific discipline, engineering, pharmacy or another relevant scientific discipline;
- Minimum 5 years of professional experience in management of Quality Management System, of which 3 years Minimum of professional experience relating to medical devices;
- In-depth knowledge of relevant European regulations and standards, such as ISO 13485:2016, EN ISO 13485:2016/A11:2021 and 21 CFR Part 820 of FDA;
- Strong project management skills and the ability to prioritize and manage multiple projects simultaneously;
- Excellent understanding of the product development process and the ability to apply regulatory requirements to each stage;
- Experience in interacting with Notified Body regulatory authorities/agencies and managing regulatory inspections and audits;
- Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to both technical and non-technical stakeholders;
- Strong analytical and problem-solving skills, with the ability to identify and resolve regulatory issues effectively;
- Demonstrated ability to work collaboratively in cross-functional teams and effectively influence stakeholders at all levels;
- Fluent in English.

This announcement is addressed to both sexes, in according to laws 198/2006, and to people of all ages and all nationalities, pursuant to legislative decrees 215/03 and 216/03