Quality Associate
hace 2 semanas
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $35 billion and approximately 130,000 employees in more than 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
Reporting to the Supplier Quality Lead, the Quality Associate is responsible for supporting the establishment of a world-class Thermo Fisher Diagnostics Quality Management System. Thermo Fisher Diagnostics (TFD) is a $700 million, multi-national business operating across the breadth of the European commercial region. This role is responsible for supporting and small, medium, and large projects for the Quality and Regulatory TFD organization across the TFD commercial entities - including UK, Ireland, Spain, Portugal, Italy, France, Netherlands, Belgium, Norway, Sweden, Denmark, Finland, Poland, Germany, Austria and Switzerland. The role will be responsible for leading, coaching, and developing an internal audit team for TFD, consistent of team members who perform internal audits as a part of substantive duties and come from various parts of the Thermo Fisher Scientific business.
Supporting TFD’s commercial services - sales and marketing, distribution, importation, warehousing, customer services and field service operations - to the multiple divisions within the Specialty Diagnostics Group (SDG), the role is accountable for ensuring the quality system of TFD interfaces seamlessly with those of the Divisions it supports and meets the needs of local and international regulations and standards, such that compliance risks are understood and mitigated to avoid impact to the business. The incumbent requires significant experience in
managing operational quality matters to ensure the quality system is maintained and effective.
This position will support our ISO 13485 and ISO 9001 compliant Quality and Regulatory processes, which covers sales and marketing, distribution, import, supplier quality management, warehousing, customer services and technical field service operations for diagnostics medical device products and related industries.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
**Key Responsibilities**:
- Support duties of MDR/IVDR Articles 13 and 14, related to Importer and Distributor as it pertains to the Thermo Fisher Diagnostics (TFD) Quality Management System (QMS).
- Conduct product verification activities in line with documented supplier management processes.
- Review of new products and services added to Approved Supplier List (ASL) and review if the products are controlled and verified according to Thermo Fisher Diagnostics requirements.
- Onboarding, monitoring, review, evaluation of new and current Suppliers as part of the ASL process.
- Supports Quality Assessments/ audits against Quality Standards working towards inspection readiness.
- Participate in, and conduct supplier audits.
- Support with External audit activities (including preparation and execution).
- Facilitate aspects of the Supplier Corrective Action Requests (SCARs) process, working with suppliers and driving continual improvement
- Collaborate and participate actively in quality projects
- Ensure accurate issuance, tracking, reviewing and closure for all levels of document changes.
- Management of Supplier Quality group NCRs following the QMS and procedures stablished in TFD.
- Responsible for training of other members of the Supply quality team, the Quality Management Representatives (QMR’s), and other relevant stakeholders.
- Assist the Supply Quality Lead in other Quality Assurance activities as advised.
**Minimum Requirements**:
- Science related degree (preferred).
- Minimum of 2 years of experience in a corporate environment (preferably an organization certified to ISO 13485 or ISO 9001).
- Strong Analytical and problem-solving skills required.
- Proven collaborative skills in a fast-paced environment.
- Well spoken and written English language skills (speaking additional European language would be highly regarded)
**Requirements**:
- Experience working with SAP is desirab
-
Associate Director, Commercial Quality Assurance
hace 5 días
Alcobendas, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Associate Director, Commercial Quality Assurance
hace 2 semanas
Alcobendas, Madrid, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Alcobendas, Madrid, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Alcobendas, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Associate - Quality Assurance Drug Product External
hace 2 meses
Alcobendas, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Senior Engineer Identity
hace 2 semanas
Poligono Industrial Alcobendas, España Straumann Group A tiempo completo**Job Purpose**: **Main Tasks and Responsibilities**: - Project Management: Lead in the planning, execution, and delivery of IAM projects. Ensure adherence to best project management practices, facilitate iterative planning, and drive the team towards successful project completion. - External Resource Management: Collaborate with external partners,...
-
Margin Optimisation Manager
hace 2 semanas
Poligono Industrial Alcobendas, España RS A tiempo completo**Margin Optimisation Manager** **Location: Madrid / Barcelona** **Remote/Office/Hybrid: Hybrid** **Employment Type: Permanent** **About the role** This is a role which requires laser focus on two key areas for the business: 1) strategic development and implementation of the Commercial Policy and 2) tactical optimisation of the achieved...
-
Clinical Research Associate II
hace 1 mes
Alcobendas, España Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our...
-
Emea Bto Business Analyst Associate Manager
hace 1 semana
Alcobendas, España Arrow Electronics, Inc. A tiempo completoPosition: EMEA BTO Business Analyst Associate Manager **Job Description**: What You Will Be Doing at Arrow? - Planning, managing, and controlling the activities of a team that provides operational support for a business segment - Managing staff of business analysts by insuring the respect of tasks and documents quality and respect of deadlines (User...
-
Emea Bto Business Analyst Associate Manager
hace 2 semanas
Alcobendas, España Arrow Electronics, Inc. A tiempo completo**Position**: EMEA BTO Business Analyst Associate Manager **What You Will Be Doing at Arrow?** - Planning, managing, and controlling the activities of a team that provides operational support for a business segment - Managing staff of business analysts by insuring the respect of tasks and documents quality and respect of deadlines (User Stories,...
-
Global Suppliers Auditor
hace 1 mes
Alcobendas, España Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Clinical Research Associate I or II
hace 3 semanas
Alcobendas, España Precision Medicine Group A tiempo completoPrecision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages.CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two studies setting you up to be a...
-
Field engineering Program
hace 1 mes
Alcobendas, España FieldCore A tiempo completoDescription FieldCore is looking for engaged and drivenindividualswith a passion for engineering to join our Field Engineering Program and Technical Field team based in Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of...
-
Field Engineering Program
hace 2 semanas
Alcobendas, España FieldCore A tiempo completoDescription FieldCore is looking for engaged and drivenindividualswith a passion for engineering to join our Field Engineering Program and Technical Field team based in Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of...
-
Field Engineering Program
hace 4 días
Alcobendas, España FieldCore A tiempo completoDescription FieldCore is looking for engaged and drivenindividualswith a passion for engineering to join our Field Engineering Program and Technical Field team based in Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of...
-
Outage Manager
hace 3 semanas
Alcobendas, España FieldCore A tiempo completoDescription FieldCore, part of GE Vernova is looking for an exceptional Outage Manager for GT26 to join our Field Operations team based in the Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of Advanced Research, Consulting...
-
Outage Manager
hace 3 semanas
Alcobendas, España FieldCore A tiempo completoDescription FieldCore, part of GE Vernova is looking for an exceptional Outage Manager for Steam to join our Field Operations team based in the Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of Advanced Research, Consulting...
-
Instrumentation & Controls Technician Remote, Spain
hace 2 semanas
Alcobendas, España FieldCore A tiempo completoDescription About GE Vernova GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of Advanced Research, Consulting Services, and Financial Services. Building on over 130 years of experience tackling the world’s challenges, GE Vernova is...
-
Outage Manager
hace 2 semanas
Alcobendas, España FieldCore A tiempo completoDescription FieldCore, part of GE Vernova is looking for an exceptional Outage Manager for Steam to join our Field Operations team based in the Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of Advanced Research, Consulting...
-
Experienced Technical Field Advisor
hace 1 mes
Alcobendas, España FieldCore A tiempo completoDescription FieldCore is looking for an exceptional Mechanical Field Engineer and Technical Field Advisor to join our Field Operations team based in Spain. GE Vernova is a planned, purpose-built global energy company that includes Power, Wind, and Electrification businesses and is supported by its accelerator businesses of Advanced Research,...
