Responsible for management of the Quality function and Quality Engineering supporting commercial manufacturing. Taking responsibility for the development, implementation, and improvement of an effective quality management system, planning and implementing the Quality System strategy in compliance with FDA QSRs, MDD/EUMDR, EN ISO 13485 and related industry guidance/standards.
DUTIES AND RESPONSIBILITIES:
Act as the Quality Management Representative and Person Responsible for Regulatory Compliance for the company. And as such manage the Quality Control inspection and testing functions (IQA, In-Process, Lot Release, RGA).
Manage quality engineering support for commercial and clinical products by collaborating with engineers and provide oversight on areas such as Supplier Quality, NCMR investigation and approval, complaint investigations, RGAs, product impact assessment, etc. Provide Quality support to R&D and commercial product projects and Quality Assurance support for facilities related activities.
Manage all aspects of FDA, EU MDD/MDR, ISO 13485 and supplier audits as well as internal audits (includes audit readiness, SME coaching, back-room logistics, planning of audits), and follow up activities such as corrective and preventive actions.
Fulfil GMP and activities related to the quality system (trainings, annual review of documents (e.g. SOPs, WI, Specifications), approval and review of procedures) within the company.
Lead investigations into major quality related issues including performing root cause analysis, and implementation of preventive and corrective actions.
Support process changes and line expansions for commercial and new product development projects and implement as well as update Quality Plans supporting major projects
Maintain current knowledge of local and international regulations and guidances regarding combination products including but not limited to; QSR, ISO, etc.
Develop, trend and report quality metrics during Quality and Management Reviews.
Plan and implement strategic initiatives designed to increase efficiencies, improve systems, and ensure quality, reliability, and compliance.
Hire, train, develop and manage Quality staff.
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
Bachelor's degree in Engineering/Life Sciences
8 years of experience with medical devices, pharmaceutical or similar technical field (5 years in Quality)
5 years of supervisory experience
Internal Auditor, Quality Engineer or other certification from a known organization is desired (i.e. ASQ, BSI)
Experience with improvement tools such as Six Sigma, Lean manufacturing is preferred.
SKILLS AND COMPETENCIES:
Must be fluent in German and English with excellent verbal and written communication skills.
Excellent communication and organizational skills (e.g. management of tight deadlines, changing priorities)
Very good analytical skills and ability to work independently