Quality assurance specialist

Quality assurance specialist

Sökord: ISO 13485, IVD, QA, Risk Management

The Quality department at Cepheid is growing and is therefore looking for a Senior Quality Assurance Scientist (Sr QA Scientist). As a Senior QA Scientist you will represent QA on different core teams during product life cycle. The Sr QA Scientist will provide design control and risk assessment expertise for product development and ensure design traceability and conduct audit of design file data. With use of technical, scientific and regulatory requirements skills, the QA Scientist support core teams for sound technical and tactical decisions. The QA Scientist works in a QA Design team including two QA analysts. In collaboration with the team the Sr QA Scientist is responsible for approvement of design files and design reviews, and ensure required deliverables are documented. Document post-market surveillance and ensure post-launch changes compliance is also included in the role.

Work responsibilities
  • Exercises judgment within defined standards and procedures to determine appropriate actions
  • Develop and track project plans
  • Adheres to technical standards
  • Monitors policy procedures and work instructions to ensure their continuous implementation
  • Recommends changes and process improvements
Qualifications:
  • University degree in engineering, science or equivalent.
  • At least three years of experience in Quality Assurance within Med Tech or IVD industry preferably from product development and life cycle management
  • Knowledge of risk management
  • Excellent skills in English both in written and verbally
  • Experience of In Vitro Diagnostics and ISO 13485
Meritorious:
  • ISO14971
  • 21CFR Part 820
  • 510k and PMA submission process
  • 98/79 EC Directive, IVDR 2017/746
  • Fluent Swedish
To be success full in this role we think that you have personal attributes such as:
  • Strong leadership and excellent communication skills
  • High level of interpersonal skills
  • Self-motivated with ability to own initiatives
  • High adaptability and flexibility
  • Careful and thorough
  • Delegate responsibility
  • Ability to keep overview and keep focus
  • Excellent organizational skills
  • Multi-tasking ability
  • Systematic
Business:
Cepheid

City:
Solna

Employment:
Open ended full time

Last date of application:
2018.01.31, Apply as soon as possible as we assess candidates contiuously.

For information:
In this recruitment Cepheid is collaborating with Dfind Science & Engineering. For questions please contact responsible recruitment consultant Ellinor Crafoord 0733-434502. Apply via www.dfind.se/science-engineering as soon as possible.

Organization and Business description:

Cepheid is one of the fastest growing companies in molecular diagnostics. The company's unique diagnostic platform is used throughout the world, making a difference for patients as diagnosis and choice of treatment is facilitated by the test results. Cepheid offers a broad range of diagnostic products in virology, bacteriology and oncology that can meet tomorrow's demands for safe, fast and flexible diagnostic both in Western countries and in countries with limited resources. Globally, the company is represented by its headquarters in Sunnyvale, California, sales and marketing offices in Toulouse, France and technology and chemistry center in Bothell, Washington. Cepheid AB, part of the global Danaher group, is located in Solna, Sweden and has around 250 employees, mainly in production, quality control, research and development.
Mer info
Kontaktperson Ellinor Crafoord
Telefon 0733434502
Område Solna
Yrkesroll Industri & Anläggning, Quality Assurance, Teknik & Ingenjör
Typ av anställning Heltid
Rekrytering hanteras av Dfind Science & Engineering
Sista ansökningsdag löpande (8 dagar kvar)