"A trustworthy partner for the IVD industry and R&D labs seeking premium immunoassay components."Henrik Christensen, CEO and owner of Kem-En-Tec Diagnostics

Job opportunities


Quality Assurance Manager – Life Science

 

Operational and strategic role within a flat organisation

 

Kem-En-Tec Diagnostics is a successful and financially strong Danish company – and Europe’s leading producer of ELISA substrates and buffers for immunoassays.

The company delivers ELISA, immunoblotting and immunohistochemistry components to biotech, pharmaceutical and immunoassay manufacturers and research laboratories in more than 30 countries worldwide.

The company excels at offering customers an optimum mix of services, which are unique within its field. Kem-En-Tec has established a US based inventory and shipping facility, and has created a strong foothold in the US market.

The company headquarters and the manufacturing facility are located in Taastrup, the Greater Copenhagen Area, Denmark. Learn more at www.kem-en-tec.com

 

 

Are you ready to spearhead Kem-En-Tec’s continuous positive expansion?

This could be your next career step as overall responsible for all QA activities and some regulatory aspects. As Kem-En-Tec wants to become ISO 9001 certified, you would have an important task further developing and improving the QA system and develop QA as an integrated business. Besides, you will be the company’s most important QA sparring partner both internally and towards customers and suppliers. You will report directly to Kem-En-Tec’s CEO. In overview, you will:

  • Be responsible of interpreting, preparing and implementing quality regulations, procedures and requirements
  • Monitor and follow up on quality and compliance issues
  • Prepare and lead internal -, customers – and supplier audits
  • Handle non-conformities and company complaints
  • Monitor suppliers and sub suppliers
  • Participate in cross functional projects dealing with, R&D, Production and Sales

Kem-En-Tec has a flat organization, and therefore you will be close to all strategic decisions across the organization in close cooperation with the CEO. You are offered great challenges and freedom with the possibility to further develop your role and see direct results of your effort. Furthermore, you will work with a large and varied network of external business partners in Denmark and internationally.

 

Experienced QA Specialist with solid ISO knowledge

You have a Master of Science in Pharmacy, Bio Science or Chemistry, or you hold a Bachelor’s degree combined with a few years of relevant QA experience. You master English fluently both orally and written. You must have experience and active knowledge of ISO 9001 (FDA and or IVD knowledge will be an advantage). Alternatively, you have knowledge or experience with ISO 13485.

Your QA work experience can be from a similar company, either a medical device or a pharmaceutical or another related industry. Here, you have gained practical knowledge working with QA management systems, regulations, compliance and company complaints.

Moreover, you possess strong communication skills, which you employ to implement the various QA initiatives and to guide your colleagues in how to live up to a satisfactory quality level. By nature, you are driven by independently managing projects and day-to-day challenges in an international environment.

As you will be the company’s most important and only QA specialist, you must be able to work individually and customer orientated, relying on your professional competencies.


Please apply via www.hansentoft.dk. If you have any questions, please call Hansen Toft at 7025 0407.

Please note that we only need your cv if you want to apply. Your application will be handled with confidentiality.

NB: The job ad will be regularly placed on various job portals. All this indicates that the recruitment process has not been finalised – not that it has started over again.