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.

Responsibilities:

• 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.

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