Head of Quality and Regulatory Affairs 100% (m/f/d)

About the job

Belimed Life Science AG, headquartered in Sulgen (CH), operates as an independent corporation within the SteelcoBelimed Group. The internationally active SteelcoBelimed Life Science corporate group employs over 500 people worldwide and is one of the leading providers in special plant engineering for machine cleaning and sterilisation in the fields of Life Science, Pharma, Biopharma and Cosmetics. Together with the Business Units SteelcoBelimed Infection Control, the SteelcoBelimed Life Science Group employs more than 2200 people at 27 locations in Europe, America and Asia.

Fancy working with hot steam and purest water? Then apply with us as:

Fancy working with hot steam and purest water? Then apply with us as:

Your tasks

The Head of Quality is the direct contact person regarding the area of expertise they lead. You implement and manage the quality processes as well as the management system of Belimed Life Science AG. You ensure that the organisation is aware of and complies with the requirements according to EN ISO 13485, ASME, DGRL as well as the general GMP requirements according to FDA guidelines. You take responsibility for handling non-conforming products and complaints and coordinate corresponding corrective and preventive measures. In addition, you act as a contact person regarding quality management for customers and suppliers.

The main tasks include:

• Implementation of the company strategy and objectives

• Supporting the organisation in implementing and managing required quality processes.

• Defining the certification strategy in cooperation with the CEO and coordinating the certification of the quality management system with the notified body.

• Ensuring that the organisation is informed about Life Science GMP requirements such as material declaration and verification, GMP processes, FAT/SAT procedures, validation, etc.

• Supporting the organisation in establishing an appropriate training level according to customer needs.

• Ensuring compliance of distributors and subcontractors, including certification, training levels and regulatory compliance.

• Coordinating and handling deviations and investigations to ensure the effectiveness of corrective and preventive actions.

• Supporting customer complaint management.

• Evaluating the effectiveness of quality controls.

• Coordinating and obtaining pressure equipment approvals for new products and/or in new countries.

• Developing and reporting required quality performance indicators (KPIs).

• Preparing the management review for the executive management.

• Acting as the main contact person for customers in quality-related matters (e.g. supplier questionnaires, audits); coordinating customer audits with suppliers of outsourced processes.

• Conducting internal and supplier audits (e.g. subcontractors).

• Defining, introducing and revising company-specific quality documents and work instructions.

• Supporting the implementation of change requests.

• Monitoring the implementation of 8D reports.

• Acting as overall project manager for the introduction of quality software CAQ (Computer Aided Quality).

The responsibilities include:

• Implementation and management of the quality management system of "Belimed Life Science AG" by the QM manager.

• Role of QA: decision-making regarding the release of FAT, delivery, concessions and delivery stops.

• Cooperation with design for the release of nameplates (e.g. test marks).

• Cooperation with the head of design to prepare declarations of conformity.

• Leading the QA team in Sulgen, Grosuplje and the USA.

The main tasks include:

• Implementation of the company strategy and objectives

• Supporting the organisation in implementing and managing required quality processes.

• Defining the certification strategy in cooperation with the CEO and coordinating the certification of the quality management system with the notified body.

• Ensuring that the organisation is informed about Life Science GMP requirements such as material declaration and verification, GMP processes, FAT/SAT procedures, validation, etc.

• Supporting the organisation in establishing an appropriate training level according to customer needs.

• Ensuring compliance of distributors and subcontractors, including certification, training levels and regulatory compliance.

• Coordinating and handling deviations and investigations to ensure the effectiveness of corrective and preventive actions.

• Supporting customer complaint management.

• Evaluating the effectiveness of quality controls.

• Coordinating and obtaining pressure equipment approvals for new products and/or in new countries.

• Developing and reporting required quality performance indicators (KPIs).

• Preparing the management review for the executive management.

• Acting as the main contact person for customers in quality-related matters (e.g. supplier questionnaires, audits); coordinating customer audits with suppliers of outsourced processes.

• Conducting internal and supplier audits (e.g. subcontractors).

• Defining, introducing and revising company-specific quality documents and work instructions.

• Supporting the implementation of change requests.

• Monitoring the implementation of 8D reports.

• Acting as overall project manager for the introduction of quality software CAQ (Computer Aided Quality).

The responsibilities include:

• Implementation and management of the quality management system of "Belimed Life Science AG" by the QM manager.

• Role of QA: decision-making regarding the release of FAT, delivery, concessions and delivery stops.

• Cooperation with design for the release of nameplates (e.g. test marks).

• Cooperation with the head of design to prepare declarations of conformity.

• Leading the QA team in Sulgen, Grosuplje and the USA.

Your profile

• Bachelor’s degree in (Electrical Engineering or Mechanical Engineering)

• German as mother tongue, English at advanced C1 level

• At least 5 years of relevant professional experience in the Life Sciences sector

• Proven several years of experience as a quality manager or in a leadership position within a quality assurance organisation.

• Guidelines, regulations and standards for Life Sciences, e.g. EN ISO 13485, ASME, DGRL, GMP, ...

• Expertise in regulations and standards in the field of pressure equipment, sterilisation and washing/disinfection technologies is desirable.

• MS Office (required), SAP or similar ERP systems (advantageous)

• German as mother tongue, English at advanced C1 level

• At least 5 years of relevant professional experience in the Life Sciences sector

• Proven several years of experience as a quality manager or in a leadership position within a quality assurance organisation.

• Guidelines, regulations and standards for Life Sciences, e.g. EN ISO 13485, ASME, DGRL, GMP, ...

• Expertise in regulations and standards in the field of pressure equipment, sterilisation and washing/disinfection technologies is desirable.

• MS Office (required), SAP or similar ERP systems (advantageous)

Our offer

With us, you can expect more than just a workplace – you will become part of a team that lives cohesion, development and joy at work. We actively support you on your career path, promote your further education and language skills, and ensure a successful start with cross-departmental induction and individual introduction plans.

In addition to exciting tasks, you benefit from attractive benefits: discounted gym memberships, free parking spaces, discounts on Miele products, full pay during maternity and paternity leave as well as 90 days of 100% continued pay in case of accident or illness.

And because success is even more enjoyable as a team, we enjoy shared moments – whether over a coffee break or at the after-work gathering at our in-house cultural square.

In addition to exciting tasks, you benefit from attractive benefits: discounted gym memberships, free parking spaces, discounts on Miele products, full pay during maternity and paternity leave as well as 90 days of 100% continued pay in case of accident or illness.

And because success is even more enjoyable as a team, we enjoy shared moments – whether over a coffee break or at the after-work gathering at our in-house cultural square.

Become part of our successful team and advance your career.