Quality System Manager
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.hpsearch.se
Quality System Manager, Design Assurance Instrument and Software
How will you make an impact? We are recruiting for a Quality System Manager, as the Design Assurance for Instruments and Software you are responsible for supporting Product Development projects by providing input to the development teams, authoring or approving Design Control deliverables such as Quality Plans, Project Plans, Document Plans, and Design History File. You will also be responsible for providing guidance and coaching for product sustaining activities, such as design changes and CAPA (Corrective and Preventive actions). The Product Quality group is part of the Global Quality Assurance team and consists of 6 people, the group has responsibility for Design Control activities, Risk Management, Post Market Surveillance, CAPA and Complaint handling
What will you do?
- Establish Quality Plans for product development projects.
- Provide guidance for application of Design Control i.e. Design and development planning, Design input (e.g. specifications), Design reviews, Product verification and validation, Risk management, Usability engineering and Design transfer etc.
- Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, applicable regulatory requirements and international standards.
- Provides support to post market design changes, including assessment of proposed changes using design control methods.
- Participate in team projects and assignments, facilitating or leading teams as necessary.
- Identify the opportunities for continuous improvement of the Quality Systems.
- University degree in medical/technical sciences
- Minimum of 5 years in a medical regulated industry including 3-5 years in a Design Assurance role for IVD instruments and Software or Medical Devices
- In depth knowledge in working with quality management systems in an IVD/Medical device environment (e.g. QSR, EU medical directive, ISO 13485, ISO14971) for a number of years.
- Excellent verbal/written communication skills; fluent in Swedish and English
- Personal Skills
- Strong interpersonal skills, driving cross-functional collaboration
- Strong ability to drive tasks/projects to closure in a timely fashion
- Ability to organize work, can decide about and reach objectives for the projects and the processes
- Ability to work independently & as part of a team.
- Ability to influence & negotiate with people & resolve issues.
- Ability to make rational, objective & appropriate decisions relating to company & department needs
If this sounds interesting to you, contact one of us below for more information. Alternatively, you can apply directly by uploading your resume and by emailing us a line.
We look forward to your application!
H&P Search & Interim
+46 (0) 703 778 774