Quality Management Representative - Barcelona, España - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

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 sophisticated analytical challenges, improve patient diagnostics and increase laboratory productivity.

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 enable 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.

How will you make an impact

As a European Quality Specialist of Thermo Fisher Diagnostics (TFD), a $700 million multi-national business operating across the breadth of the European commercial region, you will provide operational direction, leadership and drive the successful implementation, maintenance and improvement of a robust Quality and Regulatory system in the assigned regions and for the assigned functions.

Being a member of a European team of Quality management representatives and supporting TFD's commercial operations (sales and marketing, distribution, importation, warehousing, customer services and field service operations) of the multiple divisions within the Specialty Diagnostics Group (SDG), you will ensure that the ISO 9001 and ISO 13485 certified quality management system is effective and meets the needs of local and international regulations and standards.

The role requires significant experience in managing operational quality (and regulatory) matters within a medical device business

What will you do

As a member of the European team of Quality and Regulatory Management Representatives, key responsibilities include:

Responsible, through assigned activities, for the effective implementation, monitoring, and ongoing maintenance of the TFD-QMS. This covers the breadth of regions where the QMS is deployed, as well as supporting expansion and new QMS deployment activities. Specifically, ISO9001 and ISO13485 certifications for the sites and processes are in scope, with the expectation to be working closely with a range of business partners
Ensure the processes needed for the Quality Management System (QMS) are established, implemented, adhered to, and continuously improved: Procedures and records Management, Change Control Management, Complaints, Non-Conformance Reporting (NCR), Corrective and Preventative Action (CAPA), Internal and external Audits, Regional Management reviews, regulatory requirements for the Medical Device Regulations (MDR) and Invitro Diagnostic Regulations (IVDR).
Collaborate with the other members of the TFD Quality and Regulatory team to develop alignment and harmonization of the Quality system across Europe
Communicate and coordinate as needed with TFD business partners and other interested parties (customers, suppliers, subcontractors, distributors, national competent authorities, product manufacturers etc.) necessary activities including but not limited to audits, trainings, management reviews, Complaints/ Field Safety Corrective Actions/ Product recall/ NCR/ SCARs/ CAPAs handling
Mentor and develop TFD employees supporting Quality activities
Foster the development of a "Right the first time with the customer in mind" Quality culture throughout all functions of TFD
Partner and collaborate with other Thermo Fisher Scientific business units to continuously improve regulatory and quality matters impacting the business.
Other duties as assigned by acting manager as the need arises.

Additional Specific responsibilities include**:

Process Quality Lead (PQL): Supply chain management (incl. Warehousing)
Coordinate and drive TFD-QMR team activities across Europe for
Warehousing
Process and software validation
Customer requests for quality agreements and other questionnaires

Who are we looking for

Track experience of working with ISO9001, ISO13485, GxP and strong Quality and compliance knowledge
Knowledge of IVDs and Medical devices
Degree in Engineering, Biological Sciences, Chemistry, Biochemistry or equivalent preferred.
A certified training in lead auditing of quality systems; ISO 13485 and/or ISO 9001 would be an asset.
Excellent oral and written communication skills
Capability of working independently and in self sufficiency
Ability to work in a matrix organization
Strong interpersonal skills are necessaries. You will be required to formally present at meetings and influence a wide variety of collaborators across various functions
Customer centric and int