Director of Quality, European Operations
Director of Quality, European Operations
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position:
Under general supervision and in alignment with the Sr. Director of Quality Operations for Sunnyvale and Europe defines and executes strategies to assure compliance to the quality system and international regulations of the medical industry by managing the quality operations and quality engineering teams and in collaboration with all local and corporate functions to guarantee and maintain the quality of manufacturing processes finished product and regulatory compliance.
Roles and Responsibilities:
- Direct responsibility for the European Operations including Biebertal Emmendingen and Freiburg at Germany as well as Parmovay Bulgaria.
- Responsible for the quality functions including IQC MRB PMC FQI DHR and Quality Engineering.
- Develop site and regional strategies to ensure alignment with our company goals and customer expectations pursuing continuous improvement in our metrics.
- Creates an environment that is inclusive and diverse allowing employees to be their authentic selves while motivating them to produce their best work.
- Fosters an inclusive culture built around diversity of thought collaboration and teamwork across organizational and geographical boundaries; willing to break down functional silos to optimize business results and to facilitate the overall growth of the company.
- Proactively manages quality assurance and compliance activities to produce the highest quality products and prevent defects.
- Create monitor and control the quality operations budget for the facilities under responsibility.
- Collaborate with the operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results.
- Track recurring issues and escalating as needed to achieve root cause corrective action.
- Collect monitor and escalate product quality data and partner with the appropriate function to resolve problem parts supplier processes etc. to closure.
- Develop trend and improve appropriate quality operational metrics.
- Provides support and guidance to lead adhering to our internal procedures and regulatory requirements.
- Performs Organization Talent Plans to assure the identification of talent needs and the development of adequate growth plans.
- Plans resource requirements based on the company growth projections and longterm strategies.
Qualifications :
Required Knowledge Skills and Experience:
- Education:
- Electronics Biomedical Industrial education or other related engineering
- Other studies:
- Certification in Six Sigma
- Desirable MBA desirable Certified Lead Auditor desirable
- Certification in Six Sigma
- English language skills: Written and spoken
- German fluency highly desirable
- Systems Management:
- Advanced level of Office Package
- Intermediate level of SAP
- Preferably Intermediate level of Agile
- Job or area experience:
- Quality Director/manager
- Quality areas
- Medical industry
- Knowledge / skills:
- Knowledge of Statistical Tools such as MSA (Measurement System Analyst)
- Knowledge of ISO 13485
- Knowledge of medical regulations
- Drawings Reading
Additional Information :
Intuitive ist ein Arbeitgeber der gleiche und gerechte Beschftigungsmglichkeiten bietet. Wir bieten allen qualifizierten Bewerberinnen und Bewerber gleiche Beschftigungsmglichkeiten unabhngig von ethnischer Herkunft Geschlecht Schwangerschaft sexueller Orientierung Geschlechtsidentitt nationaler Herkunft Hautfarbe Alter Religion geschtztem Veteranenstatus Behindertenstatus genetischen Informationen oder einem anderen Status der nach den geltenden Gesetzen auf Bundes Landes oder lokaler Ebene geschtzt ist und verbieten jegliche Form von Diskriminierung und Belstigung.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
