Quality Assurance Specialist
vor 2 Monaten
Job Overview
The Quality Management System Specialist plays a pivotal role in ensuring the Site Quality system adheres to all applicable regulations, including cGMP. As part of the global quality assurance function, this position provides guidance to multiple departments on compliance with SHL Site Quality and Regulatory procedures, as well as Agency policies and regulations. The job holder is directly involved in establishing Site procedures.
Main Responsibilities:
- Develop and maintain the Site Quality Management System
- Oversee the implementation of quality assurance procedures
- Lead internal and supplier audits
- Support external audits
- Track key performance indicators (KPIs)
- Lead and contribute to Corrective Action and Preventive Action (CAPA) and Non-Conformance (NC) processes
- Contribute to site Quality Assurance, Regulatory Affairs (QARA) projects
- Provide training on quality assurance procedures
- Qualify suppliers, including conducting supplier audits
Requirements:
- Minimum of 3 years' experience in Regulatory Affairs, Clinical Affairs, or Quality Assurance of medical devices
- Previous experience in quality processes for medical devices
- Experience in GMP and other Regulatory compliance requirements
- Strong analytical and problem-solving skills
- Operates with unwavering ethics and integrity
- Ability to understand and adapt to diverse cultures and market needs
Preferred Qualifications:
- Certified internal auditor to ISO 13485
- Previous experience in quality management systems for medical device manufacturing organizations
Education and Training:
- Bachelor's degree in Life Sciences, Engineering, or a related field
- Certified Lead Auditor for ISO 13485 standards
We Offer:
- An exciting opportunity in a fast-growing international medical device company
- A modern working environment with multicultural and dynamic teams
- Flexible working hours and a hybrid remote work policy
- A centrally located office in Zug, close to the train station
-
Quality Assurance Specialist
vor 2 Monaten
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Quality Management System Specialist is responsible for ensuring compliance with all applicable regulations, including cGMP. As part of the global quality assurance function for the Site Quality system, the job holder will provide guidance to multiple departments regarding compliance with SHL Site Quality and Regulatory...
-
Quality Assurance Specialist
vor 1 Monat
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe Quality Management System Specialist plays a critical role in ensuring the compliance of all applicable regulations, including cGMP, within the Site Quality system. As part of the global quality assurance function, this position provides guidance to multiple departments on compliance to SHL Site Quality and Regulatory procedures, as well as...
-
Quality Assurance Specialist
vor 1 Monat
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe Quality Management System Specialist plays a critical role in ensuring the compliance of all applicable regulations, including cGMP, within the Site Quality system. As part of the global quality assurance function, this position provides guidance to multiple departments on compliance to SHL Site Quality and Regulatory procedures, as well as...
-
Quality Assurance Specialist
vor 4 Wochen
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Quality Management System Specialist is responsible for ensuring compliance with all applicable regulations, including cGMP. As part of the global quality assurance function for the Site Quality system, the job holder actively provides guidance to multiple departments regarding compliance to the applicable SHL Site Quality and...
-
Quality Assurance Specialist
Vor 3 Tagen
Zug, Zug, Schweiz AbbVie VollzeitJob Title: Commercial Quality Assurance HeadAbout the Role: We are seeking a highly skilled and experienced Commercial Quality Assurance Head to join our team at AbbVie. As a key member of our quality assurance team, you will be responsible for ensuring that all commercial activities are conducted in accordance with regulatory requirements and company...
-
Corporate Quality Assurance Manager
vor 2 Monaten
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Global Quality Systems Manager is responsible for ensuring corporate compliance to all applicable regulations, including cGMP. As part of the leading quality assurance function for the Corporate Quality system, the job holder will actively provide guidance to multiple departments and sites regarding compliance to the applicable...
-
Senior Quality Assurance Manager
vor 1 Monat
Zug, Zug, Schweiz Golem Factory GmbH VollzeitAbout Golem Factory GmbHWe are a pioneering company in the field of decentralized computing, and we're looking for a Senior Quality Assurance Manager to join our team. As a Senior Quality Assurance Manager, you will play a crucial role in ensuring the quality of our decentralized computing platform.Key ResponsibilitiesDevelop and implement comprehensive QA...
-
Senior Quality Assurance Manager
vor 1 Monat
Zug, Zug, Schweiz Golem Factory GmbH VollzeitAbout Golem Factory GmbHGolem Factory GmbH is a pioneering company in the field of decentralized computing, aiming to make computing power more accessible and affordable worldwide. We are seeking a highly skilled Senior Quality Assurance Manager to join our team and contribute to the development and innovation of our open-source, decentralized platform, the...
-
Responsible Person
vor 2 Wochen
Zug, Zug, Schweiz AbbVie VollzeitJob Description:The Responsible Person at AbbVie ensures that all business is conducted in compliance with Swiss law on Medicinal Products and company policies. This role is responsible for direct technical supervision of the operation, safety, efficacy, and quality of the medicine, and ensures proper handling of pharmaceutical products, importing, and...
-
Quality Management Systems Expert
vor 2 Monaten
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Quality Management System Specialist is responsible for ensuring compliance with all applicable regulations, including cGMP. As part of the global quality assurance function for the Site Quality system, the job holder will provide guidance to multiple departments regarding compliance with the applicable SHL Site Quality and...
-
Commercial Quality Assurance Head
vor 2 Wochen
Zug, Zug, Schweiz AbbVie VollzeitJob Description:The Commercial Quality Assurance Head will ensure that all business operations are conducted in compliance with the Swiss law on Medicinal Products, as well as with AbbVie company policies. This role will have direct technical supervision of the operation, safety, efficacy, and quality of the medicine, and will ensure proper handling of...
-
Zug, Zug, Schweiz Siemens Schweiz AG, Smart Infrastructure, Global Headquarters VollzeitAbout the JobWe are seeking an experienced Software Developer to join our dynamic and motivated development team as a Quality Assurance Engineer for Building Automation. You will be responsible for analyzing current testing processes and practices, driving improvements in a key project portfolio in the environment of building automation, and ensuring...
-
Quality Management Director
vor 1 Monat
Zug, Zug, Schweiz PSI VollzeitJob Title: Director, Quality ManagementJob Summary:We are seeking a highly experienced and skilled Director of Quality Management to join our team at PSI. The successful candidate will be responsible for leading our quality management efforts, ensuring compliance with regulatory requirements, and driving continuous improvement in our quality systems.Key...
-
Quality Management Director
vor 4 Wochen
Zug, Zug, Schweiz PSI VollzeitJob Title: Director, Quality ManagementJob Summary:We are seeking a highly experienced and skilled Director of Quality Management to join our team at PSI. The successful candidate will be responsible for leading our quality management efforts, ensuring compliance with regulatory requirements, and driving continuous improvement in our quality systems.Key...
-
Commercial Quality Assurance Head/FvP
Vor 6 Tagen
Zug, Zug, Schweiz AbbVie VollzeitJob DescriptionThe Responsible Person Immunogen GmbH ensures that all business is conducted in compliance with the Swiss law on Medicinal Products, as well as with Immunogen GmbH company policies. The FvP is by law responsible for direct technical supervision of the operation, safety, efficacy and quality of the medicine, and ensures in particular the proper...
-
Senior Quality Management Director
vor 2 Wochen
Zug, Zug, Schweiz PSI VollzeitJob SummaryThe Senior Quality Management Director will oversee the development and implementation of quality management systems, ensuring compliance with regulatory requirements and industry standards. This role will also be responsible for managing quality assurance audits, facilitating training and development programs, and providing guidance on quality...
-
Global Quality Systems Manager
vor 2 Monaten
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Global Quality Systems Manager is responsible for ensuring corporate compliance with all applicable regulations, including cGMP. As part of the leading quality assurance function for the Corporate Quality system, the job holder will provide guidance to multiple departments and sites regarding compliance to the applicable SHL...
-
Director of Quality Management
vor 3 Wochen
Zug, Zug, Schweiz PSI VollzeitJob Title: Director, Quality ManagementJob Summary:We are seeking a highly experienced and skilled Director of Quality Management to join our team at PSI. The successful candidate will be responsible for leading our quality management efforts, ensuring compliance with regulatory requirements, and driving continuous improvement in our quality systems.Key...
-
Global Quality Systems Director
vor 1 Monat
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Global Quality Systems Manager is responsible for ensuring corporate compliance to all applicable regulations, including cGMP. As part of the leading quality assurance function for the Corporate Quality system, the job holder actively provides guidance to multiple departments and sites regarding compliance to the applicable SHL...
-
Regulatory Compliance Specialist
vor 2 Monaten
Zug, Zug, Schweiz SHL Group VollzeitJob OverviewThe position of Global Quality Systems Manager is responsible for ensuring corporate compliance to all applicable regulations, including cGMP. As part of the leading quality assurance function for the Corporate Quality system, the job holder will actively provide guidance to multiple departments and sites regarding compliance to the applicable...
