Interim - Head of Quality - IVD (m/w/d)
Proclinical are recruiting for an Interim - Head of Quality - IVD (m/w/d) to join an organisation. This role is on a contract basis and is located in Germany.
- Handle the quality budget, which involves capital expenditures, headcounts and expenses.
- Cooperate with any other divisions, which involves R&D, manufacturing, and supply chain, to guarantee quality is built into every attribute of the company's products and processes.
- Recognise and execute best practices and constant improvement initiatives to advance the quality system and drive effectiveness.
- Offer training and assist all divisions on quality-linked concerns, which involves corrective and preventative actions, risk management and validation.
- Guarantee compliance with all suitable guidelines, regulations and standards which involves ISO, MDSAP, etc.
- Form and uphold efficient relationships with regulatory authorities and customers in promoting adequate and effective discussion pathways.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in an engineering, scientific, or a similar discipline though a master's would be ideal.
- At least 10 years of experience within quality assurance and control, ideally within a medical device or IVD organisation.
- Know-how of quality management systems, guidelines and standards which involves FDA 21 CFR 820, ISO 13485, IVDR 2017/746 and any other significant regulatory bodies.
- Acquaintance with lean six sigma strategies would be beneficial to the role.
If you are having difficulty in applying or if you have any questions, please contact Ciro Civale at +49 69 50955443.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.