Quality Assurance Manager

Quality Assurance Manager

Employer

Steelco S.p.A – HQ

Location

Via Balegante 27

Riese Pio X (TV)

Italy

Department

Quality Assurance

Type of work

Full time (8.00 - 17.00)

Steelco and Belimed have joined forces to lead the way in advanced cleaning and sterile workflow solutions. This partnership is powered by our united strengths: a dynamic product range, relentless innovation, utmost reliability, and an unmatched commitment to customer satisfaction. As SteelcoBelimed, we “Innovate with confidence”, as we set new industry standards to meet our customer’s needs offering high-quality products and comprehensive services for Infection Control and Life Science.

Your Role

The Quality Assurance Manager is responsible for ensuring that quality standards and continual improvement processes are implemented and maintained in alignment with regulatory requirements and customer expectations laid out in the group’s strategy. This role oversees the quality management system, supervises CAPA (Corrective and Preventive Actions) processes and ensures that the Quality Assurance team (both in Riese and Cusano plant) is lead and developed to fulfill the team’s targets.

The Quality Assurance Manager is driving together with the Manager team of the Quality Management and Regulatory Affairs department in Italy the Post Merger Integration (PMI) mainly the transformation of the Quality Management System according to the defined strategy by the Executive Group Management of the SteelcoBelimed group.

Tasks & Responsibilities

Responsible for maintaining, improving and implementation of the Quality Management System.

Controls the cases in the CAPA Management System regarding

Documentation quality

Time deadlines

Efficacy of Corrective and Preventive Actions

Supports the operation of the CAPA Management System and understands the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations and reportable incidents.

Performs trainings of users in CAPA processes.

Acts as interface between users of the CAPA Management Tool (super user), determines further developments of the CAPA Management Tool.

Supports process owners in updating and improving the processes of the Quality Management System.

Prepares and executes internal audits.

Takes part during audits/inspections of Notified bodies or authorities.

Supports the Business Units and plants in quality and regulatory questions.

Supports and acts as deputy within quality management & regulatory affairs team in Italy.

Your Profile

Skills & Competencies

Directives, regulations and standards for medical devices quality systems: MDR 2017/745, EN ISO 13485, EN ISO 9001, EN ISO 14971, 21CFR Part 820 Quality System Regulation; Part 803 Medical Device Reporting; Part 806 Medical Device Corrections and Removals; Part 821 Medical Device Tracking etc.

Qualification and previous experience in conducting internal and external audits.

Expertise in CAPA analysis and monitoring.

Excellent knowledge of the Microsoft 365 suite and of the English language (C1).

Strong team work skills.

Hands on mentality

Flexibility, reliability, mediation skills, and a strong sense of responsibility.

Strong leadership and team coordination capabilities.

Required Experience

Previous experience in a similar role is prerequisite, particularly in the lead of quality management systems for medical devices and/or other regulated industries.

>5 years of experience in an international acting company as leader.

Required Education

Bachelor’s/Master’s degree in Engineering or another similar scientific discipline.

Our Offer

Work in an international, fast-growing industry that makes a real impact on healthcare and pharmaceutical industry.

Be part of an innovative and open-minded team.

Join a company with a strong reputation and long-standing expertise in cleaning and

disinfection solutions.

We offer a people-focused work environment, with dedicated benefits and welfare initiatives.

Ready to make an impact?

Apply online

The personal data contained in your resume will be processed by Steelco S.p.A., with registered office in Riese Pio X – TV, Via Balegante 27 (“Company”), for the selection process relating to this position or other similar positions. Detailed information, including information on the rights recognized by the legislation on the protection of personal data, can be found in the information notice available on the Company's website on the “Careers” page (https://www.steelcogroup.com/it/careers/).