As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than USD 17 billion in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.
At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission - enabling our customers to make the world healthier, cleaner and safer.
Quality and Regulatory Representative, Spain, Portugal and Italy
Location: Barcelona, Spain (or possibly Italy or Portugal)
Reporting to: Country Manager
Group: Specialty Diagnostics Group
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
- Lead the implementation of Thermo Fisher Diagnostics Quality Management System and serve as channel to ensure compliance with Thermo Fisher Scientific policies, divisional and local quality policies and regulations.
- Direct supervision of IVD medical devices activities by guaranteeing the:
- correct procurement and regulatory compliance for imported products
- packing and storage management
- inspection, for example review of labeling and documentation needed for distribution in the region
- shipment and transport, including adherence to import and export regulations
- installation and servicing
- Maintaining and keep up to date the technical documentation archive and authorizations generated by such operations and ensure that it is technically validated, accurate, complete and properly saved.
- Manage, processing and track of nonconforming product and set up improvement measures and programs to ensure needs of internal and external stakeholders
- Act as liaison with Competent Authorities for vigilance matters and co-operate with the implementation of the measures from manufacturers, for example, any recalls or rework, and authorities when appropriate
- Maintenance and upgrading of Quality Manual and when necessary, write, review and approve procedures and policies
- Report quality-related Key Performance Indicators, (KPI), metrics to relevant stakeholders across the company both locally and globally
- Ensure integrated control of records and documents of the Quality Management System processes are up to date
- Manage effectively customer feedback as part of the Post Market Surveillance processes including customer complaints to immediately inform of adverse events to relevant stakeholders.
- Evaluate and ensure that corrective actions plans are adequate and followed up to completion
- Plan and ensure the realization of the Annual Internal Audit Program to cover all Quality System processes
- Maintenance and upgrading ISO certification. Be the main contact point for facing follow-up and re-certification audits by third party.
- Ensure adequate internal profile auditors
- Drive appropriate Management Review processes. Arrange and participate in the Quality Management Review meetings and report minutes to Top Management. Ensuring management awareness of the compliance state, and escalation of issues where appropriate
- Encourage quality culture management and monitor training related to the Quality System. Communicate the need for compliance to members of functional areas. Bring complaint process questions/issues to the attention of the next level of management
- Monitor list of approved suppliers and keep supplier evaluations up to date
- Supporting Customer and Logistics Services in the implementation of Quality Procedures, Policies and local regulations to ensure compliance of supply chain operations
- Assist public tenders’ team by managing and providing technical documentation
- Supporting ad hoc quality projects as required and performs all other duties as assigned
- Comply with all quality, health, safety and environmental rules, policies, procedures and any other instructions relevant to working within their area of the company.
- A university degree or equivalent in a relevant science subject (Pharmacy, Medicine or Biology)
- Quality/Compliance knowledge of working with ISO standards, (e.g ISO 9001, ISO 13485, and/or ISO 14001).
- A certification/training in auditing of Quality Systems
- Ability to balance compliance requirements with customer requests and offer appropriate advice
- Capability of working independently, taking responsibility for the management of projects and timelines Capability to work across departments to implement new procedures and programs
- Ability to work in a matrix organization
- Multilingual, essential ability to speak and write English and Spanish/Italian
- Good understanding of Quality Management Systems requirements
- Previous experience from a regulated work environment, preferably within the medical device or diagnostic industry.
- Ability to speak and write Portuguese is desirable
Travel Requirement: within the Southern Europe region and abroad when required to support other locations
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.