Vanadis Diagnostics/PerkinElmer · Publicerad Igår 00:00

Vanadis Diagnostics is an exciting start-up company that develop a CE-IVD solution for prenatal screening (NIPT). We are now seeking an outstanding individual to our quality management. This is an excellent opportunity to develop quality system and quality assurance process to a new, growing innovative company.

Arbetsuppgifter

In this position you will be responsible for implementing the ISO 13485 quality system and continue to support the site in compliance. You will have the opportunity to work closely with other functions in the Turku and Boston. The position will also eventually work in a broader role towards other sites within PerkinElmer and work with quality functions within PerkinElmer Europe.

Responsibilities:
  • Establishing Vanadis Diagnostics ISO 13485 quality system
  • Ensures compliance of ISO 13485 primarily in product development
  • Oversee and assist in the development of quality control rules
  • Initiate corrective action processes resulting from customer complaints, identified non- conformance's, audits, or any other means of problem identification, audits and inspections
Utbildning/erfarenhet

Must haves
  • Bachelor's / Master's degree in engineering or natural sciences
  • At least three years of experience within Quality Systems, preferably ISO13485 or QSR.
  • Good written and verbal communication skills in English and good verbal skills in Swedish.
Merits
  • Leadership experience
  • Experience of working with IVD systems
  • Experience from establishing / implementing ISO13485 QMS
  • Experience from research and/or development under ISO13485
In addition you will need to be goal and result oriented and a team player. You are friendly, positive, and fun to work with. You have exceptional analytic and decision-making skills and you enjoy actively participating in day-to-day operations and enjoy working in a fast paced and time sensitive environment.
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Om företaget
Vanadis Diagnostics was founded 2013 in Sollentuna Sweden and is since December 2015 a wholly owned subsidiary of PerkinElmer, Inc. The company was founded to provide all pregnant woman access to high performance cfDNA tests. The company develop a complete platform for NIPT that any diagnostic laboratory can install and operate.

PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The Company reported revenue of approximately $2.2 billion in 2014, has approximately 8,000 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
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2 okt
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