Quality Management Manager

Occlutech

Helsingborg, Sweden

With our products entering the US market and new tasks for our Quality Management Department, we are strengthening the team with a Quality Management Manager. We are looking for a candidate with deep and longstanding experience in Quality Management in Class III environment, a strong quality mindset and experience of leading projects and processes.

Your work tasks will be:

Site-level Quality Management, who will champion the manufacturing quality system requirements (ISO 13485 and FDA QSR) and ensure they are effectively established and maintained as well as reports on the performance of the quality system to management with executive responsibility;
Driving key processes to include: Quality Plan Creation, Quality Training, Compliance Analysis, CAPA Management, Change Management and Document Control per ISO 13485 and FDA QSR 820;
Establishing Quality Systems that are compliant with regulatory requirements and meet business needs.

We are looking for a candidate, who:

holds a degree, Bachelor, Master or Diploma in engineering with a strong quality experience, preferably in the pharmaceutical or medical device industry;
has a minimum of 5 years’ experience in QM/QA in Class III environment in relevant regulations (e.g. MDSAP, FDA, ISO 13485);
Brings a strong quality Management experience, creative planning, and strategic approach;
has excellent interpersonal, communication and leadership skills

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