Head Global Quality and Regulatory
Vor 6 Tagen
**Your Main Functions**:
The primary role of this position is to provide global leadership, direction and hands on involvement regarding quality management system, quality control and quality improvement process for the Volpi Group. This position requires strong product development and manufacturing knowhow in a regulated industry, customer and supplier relations, and a thorough working knowledge of compliance requirements in an ISO 13485 environment.
Reporting to the Group CEO you are a hands-on leader responsible for:
- The setup, maintenance and auditing of the Group QMS according to ISO 13485, as well as the quality assurance over the product value chain for both Volpi site locations.
- Implement processes and procedures, and conduct analyses to sustain, improve, and harmonize QMS in alignment with customer, legal and regulatory requirements, as well as Volpi’s strategic direction.
- Establish and supervise adequate quality assurance and inspection processes and function at our development and production plants in the US and in CH and act as the Quality Manager of the US legal entity.
- Ensure seamless integration of the QMS throughout the business, while collaborating with individual process owners towards continuous improvements.
- Manage a small global quality team across both Swiss and US sites, and implement a performance and customer oriented, collaborative and team spirited agile culture. Empower the team members for independent, self-motivated thinking and actions.
- Manage and further develop the capabilities in the quality team and improve the technical, methodical and interpersonal skills of each team member.
- Lead and execute group training for all employees on quality management processes.
- Successfully manage, lead and/or support supplier, customer, and regulatory and internal audits, while meeting internal quality targets and commitments.
- Support process owners to establish and manage actionable key performance indicators and improve management reporting, information flow and business forecasting**.**
- Establish and maintain an external partner network for support of regulatory standards and compliance.
**Your Profile**:
- Bachelor or Master in Engineering, Science and/or technical field
- +10 years of experience in Quality_, and/or combined Quality _management roles, including 7+ years of proven experience in multi-site, ISO 13485 quality and regulatory environment
- Experience in product development, manufacturing and life cycle management
- Strong self-motivation combined with a high personal responsibility, degree of reliability, quality awareness and sense for pragmatic solutions
- Demanding and persistent, but supportive and team oriented
- Strong use of MS-Office Tools, Visio, Minitab, MS-Project
- Business fluent in English, German is an asset
- Experience with FDA, IVDR, IVDD regulated medical devices, preferred
- Ability to travel ~20% between the two sites, customers and suppliers
**What we offer**:
Independent and varied position with growth potential in a dynamic and international work environment. A highly motivated, collegial team and attractive employment conditions await you.
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