Senior Quality Assurance Professional Job Description
Senior Quality Assurance Professionals are integral to delivering high-quality products that meet the needs of laboratories. This role involves working in a highly innovative production and quality network to design, develop, and implement quality systems that ensure compliance with regulatory requirements.
Key Responsibilities:
* Develop and implement quality policies and procedures to ensure compliance with regulatory requirements.
* Conduct audits and assessments to identify areas for improvement and recommend corrective actions.
* Collaborate with cross-functional teams to design and develop quality systems that meet customer needs.
* Analyze data to identify trends and opportunities for process improvements.
* Communicate complex information effectively to stakeholders, including technical reports and presentations.
Required Skills and Qualifications:
* Bachelor's degree in a relevant technical discipline (Quality, Engineering, or Science).
* Minimum 8 years' experience in a regulated environment with a core appreciation of FDA regulations and Risk Management.
* Proven experience in QMS, process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, and validation.
* Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion.
* Computer literacy, including MS Office, and interface to product lifecycle tools such as SAP, Teamcenter, or other.
Benefits:
* Work in a dynamic and flexible environment with opportunities to grow personally and professionally.
* Collaborate with a global team of over 70,000 employees across more than 70 countries.
* Be part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible.
About Us:
We are a leader in the healthcare industry, aspiring to create better outcomes and experiences for patients worldwide. Our portfolio spans from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, crucial for clinical decision-making and treatment pathways.