Senior Quality Assurance Specialist
As a key member of our team, you will be part of a highly innovative production and quality network working to deliver high-quality products to serve the needs of laboratories of any size – today and tomorrow. Your primary responsibility will be to ensure the quality of our products by implementing quality control measures and procedures.
Proven experience in QMS is required, with a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling, and validation. Strong competencies and leadership skills are necessary to manage these areas effectively.
Prominent in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out-of-tolerance items, complaints, CAPA, continuous improvement changes, and post-production surveillance. A systems mindset incorporating a cross-technology understanding, as well as a core appreciation of risk and regulatory requirements, is essential for this role.
Act as a liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production, and Documentation Control. Focus on process design improvements and updating quality system procedures to achieve both fully compliant and lean processes.
To be successful in this position, you must have a minimum of 8 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management. You should also possess a Bachelor's degree in a relevant technical discipline, such as Quality, Engineering, or Science.
Highly motivated individuals who are passionate about developing and delivering quality solutions in close collaboration with suppliers & key stakeholders are encouraged to apply. Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion are required.
Strong communication and presentation skills are essential for presenting complex messages to an auditor/inspector in a succinct manner. Computer literacy, including MS Word, Excel, PowerPoint, and MS Project, as well as interface to Product Lifecycle tools like SAP, Teamcenter, or other software, is required. Familiarity with statistical software packages, such as Minitab, is a plus.
The ideal candidate will have a strong understanding of Immunology, Biochemistry, and Hematology diagnostic technologies, although not mandatory.