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Quality Manager

5 mesi fa

Porto Mantovano, Italia Donaldson A tempo pieno

Donaldson is committed to solving the world’s most complex filtration challenges. Employing innovation and breakthrough solutions, we are advancing filtration for a cleaner world. We look for the best people to help us succeed, offering opportunities to learn, effect change, and make meaningful contributions at work and in our communities. This is a place where you can make a world of difference.

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Solaris Biotechnology, a Donaldson brand under Life Science & Special Application that Designs and Manufactures Bioprocessing equipment, including Bioreactors, Fermenters, and Tangential Flow Filtration (TFF) systems for R&D and production purposes.

We are currently looking for a Manager Quality dedicated to Solaris Biotechnology products, processes and locations in Italy.

The position will be based in Porto Mantovano.

Key Responsibilities:

- Measure Plant Quality Performance and Drive Improvement Initiatives. In case of non-conformity, facilitate root cause analysis of the problem, definition, and implementation of preventive and corrective initiatives with support of responsible functions, validate effectiveness of actions and communicate resolution to customer in order to facilitate new business acquisition.
- Design, implement, sustain, and improve Quality Management System (customer-oriented, support and management processes), drive QMS implementation by making accountable all functions involved, attend, and ensure internal, external and customer audits, guarantee non-conformances closure, engage people to impact plant quality culture based on applicable international standards (ISO 9001:2015) in order to offer products in market competition. (All Solaris locations).
- Support Operational Excellence Initiatives. Collaborate with Plant Management to measure scrap and quality costs, analyze trends and define improvement initiatives; supervise quality of received materials, sub-assemblies and finished product identifying trends, non-conformances, and recurrences, requesting improvement actions in order to guarantee product compliance to regulatory and customer requirements and continuous improvement cycle.

Education Qualification:

- Bachelor’s degree in Science, Engineering, or related medical/scientific field.

Technical Competence & Skills:

- Experience on implementation and sustaining of Quality Management Systems (e.g. ISO9001, ISO13485, IATF16949)
- Proven Problem-Solving Skills
- Knowledge about product certifications CE/UL & ASME directives.
- Experience on cGMP and 21 CFR requirements.

Leadership Competence:

- Strong Leadership Skills
- Excellent interpersonal and communication skills
- Organized

Relevant Experience:

- 7+ years of professional experience in quality and/or regulatory management systems in a regulated environment such as bioprocessing, biopharma, medical devices, or food & beverage
- 2+ years of experience in a Managerial Role

Others (% of travel, language, etc.):

- 10-20% Travel
- Proficient in Italian & English languages

Come make a World of Difference

Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.