- Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
- Initialize, investigate, and manage timely completion of corrective and preventive actions.
- Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify, more effective tools and materials.
- Be able to interact with senior management with accountability for assigned projects.
- Assure timely collection, compiling, reporting and compliance with corporate and divisional key quality and compliance metrics for the management controls/ management review and CAPA system.
- Observe and analyze situations/ data having an impact on QA or Regulatory and take immediate action.
- Perform CAPA evaluations and investigations using analytical tools and assure timely implementation of defined actions and follow up on effectiveness monitoring.
- Perform and assure timely follow up activities in support of key quality and compliance metrics/ data goals and policy / procedural requirements.
- Plans, organizes, and prioritizes own daily work routine to meet established schedule.
- Arrange operational support for QC addendum labeling, relabeling and returns department.
- Support all daily QA tasks as instructed and according to the procedures.
- Support of internal audits.
- Assure adherence to the environmental management system requirements e.g. ISO14001.
- May provide limited work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.
- Balancing business priorities with adherence to standards.
- Bachelor’s degree plus 3-5 years of related work experience with a good understanding of specified functional area, or Master’s degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
- Quality experience (ISO 13485, FDA, Risk management,), education or experience.
- Project management experience, building relationships, stakeholder management, drive for results.
Uren per week: