Director Automation Quality

vor 2 Monaten

Hamburg, Deutschland Abbott Laboratories Vollzeit

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Abbott Automation Solutions (AAS) is currently looking to recruit a

**Director Automation Quality (M/F/d)**:
**The Position**:
The Director Quality Automation (M/F/d) will lead a distributed team in Germany and the US and reports directly to the Core Diagnostics Head of QA Instrumentation & Automation in the US. This role involves close cooperation with adjacent departments and other locations, requiring some travel. The position holder will manage a team of about 30-35 employees and will be based at the headquarters in Hamburg, requiring a significant on-site presence due to the nature of the role.

**Key Responsibilities**:

- Full operational and strategic responsibility for the quality area and promoting a high quality and compliance culture throughout the company.
- Quality Management:

- Development and implementation of quality strategies and processes.
- Ensuring compliance with quality standards and guidelines at national and international levels.
- Ensuring adherence to relevant internal and external standards.
- Monitoring and continuous improvement of product and process quality.
- Monitoring and improving quality metrics and goals.
- Managing on AAS level customer complaints and corrective actions.
- Team Leadership and Development:

- Leading and motivating the quality team.
- Promoting continuous development of employees.
- Cooperation with other departments such as Operations, R&D, and Service.
- Process Optimization:

- Identifying and implementing improvement measures to enhance process and product quality.
- Utilizing modern quality methods like Six Sigma including DMIC and PDCA cycles, Lean Management, Data Analysis and Data Representation, Root Cause Analysis.
- Audit and Compliance:

- Planning and conducting internal and external audits.
- Compliance with regulatory requirements and standards (e.g., ISO, US QSR, MDSAP).
- Ensuring permanent audit readiness.
- Risk Management:

- Assessing and monitoring quality risks.
- Developing and implementing risk mitigation measures.
- Documenting quality events and deviations.
- Establishing process and timeliness in postmarket risk assessments.
- Supplier Management:

- Monitoring and evaluating supplier quality.
- Support supplier audits and establish quality controls.
- Develop suppliers to support Abbott standards and processes.
- Design Quality Management:

- Support of R&D activities for New Product & Platform Development as well as On-Market projects
- Supports all AAS project teams for reviews and approvals in all aspects of product design control.
- Non-Conformity / CAPA Management:

- Management of all Quality Records (QRs) as part of the AAS Non-Conformity / CAPA process
- Establishment of a mature AAS CAPA process to support the sustainable correction of product and process non-conformities.

**Profile requirements**:

- Completed studies in engineering, life science, quality management, medical technology, or a related field.
- Several years of professional experience in quality management in a medical technology company operating in regulated markets, ideally with references to “in-vitro diagnostics”.
- In-depth knowledge of relevant standards and regulatory requirements, especially with FDA/US references.
- Experience in leading and developing teams and executives domestically and internationally, with knowledge of different cultures.
- Experience successfully working in a matrix management environment and managing multiple stakeholders.
- Ability to “think outside the box” and find pragmatic solutions with other departments, strong analytical skills and problem-solving competence.
- Fluent in German and English.
- Personal characteristics:

- High integrity and ethical behavior to consistently enforce quality standards.
- Resilience and stress resistance to thrive in a performance-oriented environment.
- Strong communication skills and diplomatic tact in dealing with various departments and hierarchy levels.
- Enthusiasm for innovation and openness to new technologies and processes.
- Attention to detail while maintaining strategic thinking ability.
- Customer orientation and understanding of market needs.
- Independence and initiative in implementing quality initiatives.
- Intercultural competence for collaboration in an international company.

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