Our client produces and markets innovative medical devices, thus helping to reduce infections and improving the safety of patients and customers worldwide. For this client we are currently looking for this permanent position in Baden- Wuerttemberg:
QA Manager / Quality Management Representative (m/w/d)
- Participate in executive level forums and strategy sessions that guide the development of people, programs and technology
- Implementation of Teleflex Q-standards
- Lead and manage a team (circa 8 reports) to meet the company’s quality goals and ensure standards.
- Manage the site’s quality system in compliance with regulations and in line with business needs: - this comprises all the Quality System subsystems including CAPA, Audits, Vendor management, Inspection, Validation and Design Control.
- Develop and implement Quality Systems improvement plans
- Propose solutions and lead the organization to resolve challenges in the marketplace
- Interact with internal personnel to resolve customer complaints and questions.
- Oversee the development of engineering documentation e. g. preparation and administration of technical documentation for product (Specifications, Test reports, product specifications)
- Successfully lead site through regulatory agency and corporate inspections.
- Educate the site on changing and current regulatory practices. Share best practices with facility personnel.
- Adhere to and ensure the compliance of Customer’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
- Be a role model for commitment, ethical conduct and customer focus.
- Relevant Degree with at least 10 years relevant work experience 5 years of which in Quality Management.
- Demonstrated knowledge in Quality Assurance (ISO 13485) is essential
- Experience within the medical device business (some years experience in a regulatory, quality or operations environment in either drugs or medical devices. (or equivalent education and experience).
- Knowledge of medical device classifications and compliance requirements.
- Technical writing skills preferred.
- Strong presentation and training skills is an advantage
- Fluent in German and a comprehensive understanding of English
- Additional language skills would be a plus
- “Hands-on” attitude and the willingness to deal with all the aspects of running a customer oriented manufacturing operation
- Excellent management skills with ability to influence management and collaborate with others;
- Strong problem solving skills for developing creative solutions and meeting project objectives are required.
- Skills that enable collaboration and communication, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
- Excellent analytical ability
- The ability to prioritize tasks and be able to manage several projects and customers simultaneously; and the ability to interface with all levels of management.
- Trustworthy and reliable
- Able to inspire and motivate a team
- Flexible and adaptable.
- Travel within Europe and occasionally internationally
- Able to work on own initiative and as a team player.
- Strong organizational skills with cultural awareness and sensitivity
- Good judgment and problem solving ability