Manufacturing QA specialist (Temporary position 12 months)

As a manufacturing QA specialist in our department, you have the opportunity to work closely with competent and engaged QA-colleagues as well as manufacturing departments related to all process steps from raw materials in, production of intermediates to finished products release used for in vitro diagnostic of cancer.

We focus on good collaboration between line of business and, priorities early QA involvement in projects and tasks as well as presence in production including on-the-floor sparing, process confirmation and “go-look-see”.

You will, together with a highly competent QA team take responsibility to ensure compliant and high-quality products, which imply involvement in a broad range of activities such as nonconformities, changes, equipment qualification and validations as well as continuous identification and implementation of improvements in production and QA processes. Producing reagents for in vitro diagnostic of cancer is a complex task where you will need to navigate in regulatory good manufacturing practices and authorities’ expectations while ensuring timely and effectively products to patients.

• →Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
• →Be able to work independently and take decisions/ set direction on quality & compliance issues.
• →Ensure site compliance with Regulations, ISO standards, local standard operating procedures (SOPs).
• →Serve as the Subject Matter Expert (SME) in quality processes.
• →Lead improvement activities/improvement of standards within quality management system.
• →Support, review & approve complex cross-functional investigations & root-cause analysis.
• →Support review and approve changes, equipment qualification and validation.
• →Facilitate sharing of regulatory & compliance expectations.
• →Facilitate presentation & support for audits & inspections.
• →Eliminates non-value-added practices.

• Bachelor’s or master’s degree in a Quantitative/Scientific/Technical discipline.
• +4 years of work experience in the medical device or pharmaceutical industry
• Preferably experience working with In Vitro Diagnostic and/or Medical Devices
• Strong knowledge and understanding of standards and regulations such as ISO 13485, ISO 14971:2019, IVD Regulation (EU) 2017/746, FDA 21 CFR part 11 and 820 as well as regulations covered under MDSAP
• LEAN mindset.
• Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
• Strong verbal and written communication skills
• Results oriented and willing to take accountability.
• Thrive working cross-functionally with people at all levels of the organization
• Flexible, systematic, and engaged team player
• Full fluency to read/write/speak in Danish and English on a business level.
• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.