Quality and Regulatory Cluster Representative – Nordics
Potential locations: Oslo, Norway; Uppsala, Sweden; Allerød or Roskilde, Denmark
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.
Summary of Key Responsibilities and Functions
We are seeking a Quality and Regulatory Cluster Rep., to provide operational direction and leadership for driving the successful implementation of one aligned quality management system for our commercial organization in the region, and then maintain and improve the system. Part of the responsibilities is also to represent the entities in any contact with local authorities responsible for regulation and surveillance of product safety.
The person in this role will lead a cluster of countries; Norway, Sweden and Denmark, and report directly into the Cluster Top Manager. The position is to serve as channel to ensure compliance with internal quality policies and external regulations.
Our commercial organizations are managing sales and marketing, distribution, import, warehousing, customer services and or service operations for diagnostics medical device products. The quality management system is based on the requirements of ISO 13485 and ISO 9001.
External and Internal Audits
- Manage internal and external quality audits to ensure compliance with ISO 13485 and ISO 9001
- Plan and perform internal audits
- Maintenance and upgrading ISO certification. Be the main contact point for facing follow-up and re-certification audits by certification body
Quality System Management
- Lead the implementation of the aligned quality management system in the region
- Maintenance of quality manual and top level procedures. Development and upgrading local work instructions
- Ensure control of records and documents of the quality management system processes
- Monitor list of approved suppliers and keep supplier evaluations up to date
- Supervise quality related processes, such as:
- Servicing and Installation
- Enable collaborative relationships between internal stakeholders with the overall focus of improving customer satisfaction and compliance
Regulatory Affairs and Post Market Surveillance
- 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
- Manage effectively customer feedback as part of the Post Market Surveillance processes
- Partner with the legal manufacturers in any management of notifications of products by local authorities
Non Conformities and Corrective Actions
- Drive the process for Corrective and or Preventive Action, CAPA, process
- Management and tracking of nonconforming products, set up improvement measures
Management Review and Quality Metrics
- Drive the management review processes. Arrange and participate in the management review meetings and report minutes
- Ensuring management awareness of the compliance state, and escalation of issues where appropriate
- Report quality related Key Performance Indicators, (KPI), metrics to relevant stakeholders across the company both locally and globally
Trainings on Quality System and Procedures
- Encourage quality culture management. Communicate the need for compliance to members of functional areas
- Develop, manage and monitor training related to the quality system. Training to be carried out in local language.
- A university degree or equivalent in a relevant science subject (e.g. chemistry or pharmacy)
- Quality and compliance knowledge of working with ISO 9001, ISO 13485 and/or FDA 21 CFR 820
- Ability to balance compliance requirements with customer requests and offer appropriate advice
- Capability of working independently, taking responsibility for the management of processes, projects and timelines
- Capability to lead change and work across departments to implement new procedures and programs
- Ability to work in a matrix organization
- Multilingual, essential ability to speak and write English with Scandinavian proficiancy on a professional level.
- Previous experience from a regulated work environment, preferably within the medical device or diagnostic industry.
- A certification / documented training in auditing of quality systems; ISO 13485 and or ISO 9001
- Significant experience with numerous years of administering quality systems such as complaint management, CAPA, training, etc.
- Experience in supervising or leading teams to a successful outcome is desired
Travels, 10-50%, within the country and region; Norway, Sweden and Denmark, and abroad when required
Application deadline is July 16th 2017
We look forward to receiving your application including a motivalional letter and a CV in English.
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