
Resins Quality Assurance Leadership
5 days ago
About Us
">We are a world leader in the life sciences industry, providing innovative solutions to accelerate your potential. This role offers an opportunity to make a real difference in the life sciences industry and accelerate your potential.
Key Responsibilities
- Lead the Uppsala site Quality Assurance organization and Quality Management System (QMS) as the lead Quality Management Representative.
- Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
- Accountable for setting & monitoring Quality KPI's including reporting on performance/trend insights within business reviews.
- Provide adequate QA support to Site Projects, including new product development.
- Collaborate with Global QMS systems, documentation control and training leaders as required to ensure QMS procedures, work instructions, and IT System effectively support the Uppsala organization.
- Mentor Uppsala associates on QMS requirements to cultivate effective communication style with stakeholders and establish cross-functional operating mechanisms, where appropriate to ensure Quality goals are met.
Requirements
- Bachelor's Degree in a Science or Engineering discipline.
- Extensive Experience working in Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environments.
- Senior Leadership experience within Quality Assurance/Quality Engineering.
- Comprehensive Understanding, comprehensive understanding of ISO 9001 & ISO 13485 requirements.
- Excellent Communication skills (written and oral), fluent in both Swedish & English.
- Project Management experience, managing project teams and working cross-functionally, both locally & globally.
- Analytical Skills, exceptional analytical, problem-solving & root-cause analysis skills.
- Product Life Cycle, demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls, verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management, services).
- Continuous Improvement, experienced in continuous improvement methodologies & tools (i.e. LEAN six sigma, DBS, SPC and data trending).
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