Global Quality Control Manager (f/m/x)
Structural Heart Germany

The Company:

We are representing a globally active medical device manufacturer, which was founded and is still headquartered in Germany. The mission is to bring the development, production and sales of innovative implant systems within the interventional cardiology to the next level. With roughly 350 employees globally and 120 of those in Germany, the team is working continuously for over two decades to develop new products (passive implants of risk class III). Those products are designed to provide patients with a significant improvement in quality of life, who are beyond established treatments. They follow a quality strategy and aim to increase the quality management team in the global HQ to improve the processes and align them with the overall strategy. The company is already active in roughly 90 markets and about to enter the US market. Reducing the time-to-market for the new first-in class products as an internal service provider is the main goal of this position. We are therefore searching for the manager of the global quality control on a director level, who should work from the global HQ in Jena with the potential to grow into the role as Vice President Quality in the foreseeable future.

The Position:

• Independent and autonomous management of quality control (validation, non-conformity, metrology, etc.) at the main global production sites in Central Germany and Turkey as well as other sites with associated teams
• Empathic management and development of the teams (~30 employees; 4-6 direct reports), including the overall organization, to position them as internal service provider - reporting directly into the Executive VP Regulatory Affairs & Quality
• Streamlining processes and SOPs relating to quality control as well as the responsibility for all CAPAs - in close cooperation with other departments of the organization (e.g. the production, quality assurance, regulatory affairs etc.)
• Takes over responsibility for cross-departmental and companywide projects
• Should always challenge the status quo of procedures and drive the respective innovation to ensure that projects are kept in time, in budget and quality
• Manages and supports the PRRCs (the role is split into different people)
• Coordinates with the Executive VP Regulatory Affairs & Quality the strategic approach in his department to ensure alignment of the overall strategy
• Collaborates with external contacts and partners (like test institutes or research facilities) and represents the company in the public in the field of responsibility
• Provides technical leadership and initiates innovation to enable a continuation of the successful growth story

Your Profile:

• Experienced in Quality Control within a similar regulated environment (ISO 13485, GMP, GAMP5, FDA QSR 820, ISO 22000 etc.), preferably in an international environment within the medical device industry in a comparable risk class of IIb or III
• First leadership experience with direct reports -ideally in an international background and over multiple sites
• Bachelor degree or equal in engineering, technical/ scientific discipline or related area/ equivalent background and experience
• Knowledge in validation strategies, metrology etc. on a technical level and solid understanding about the regulatory frameworks for quality control
• Excellent communicator, excellent team manager - leadership character with proven success in such a role
• Creative thinker, out of box, interested in new technologies and trends
• Excellent technical understanding
• Flexible, ethic personality
• Ownership mindset
• Interested to work with other cultures, sensitivity to cultural differences and able to facilitate them
• Fluent in English. German is a plus, but not necessary
• Achievement orientation
• Conceptual thinking
• Convincing others
• Relationship building
• Detail oriented

Your Chances:

• You are going to head a young, dynamic, international and innovative team
• The onboarding and initial training is going to be individualized according to your prior experiences
• You are joining a team with an established portfolio including monopoly products in a strong expansion phase
• The position provides you with ample decision making leeway, enables you to work flexible and influence your professional environment directly
• The excellent company culture with a flat hierarchy enables you to get things done
• You are going to find ideal foundations to grow and define your career in an expansive and dynamic company and to leave a mark in the industry as well as for the patients
• The provides you with a specific career opportunity to progress further into the next level