Job Description
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We are seeking a highly skilled and experienced Quality Assurance Professional to join our team. As a key member of the production and Quality network, you will play a critical role in delivering high-quality products that meet the needs of laboratories of all sizes.
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Key Responsibilities:
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* Proven experience in QMS working in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling, and validation.
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* Demonstrated strong competencies and leadership in these areas, with a prominent role in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out-of-tolerance, complaints, CAPA, continuous improvement changes, and post-production (proactive surveillance).
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* Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production, and Documentation Control.
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Requirements:
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Using lean tools, own and lead quality projects that deliver quality, cost, and process improvements. Assess manufacturing's capability to meet quality requirements based on data analysis and internal audit. Create concise reports that enable project teams to implement improvements and corrective actions. Experienced in the use of statistical analysis to support technical report writing to meet Quality Systems and regulatory standards of excellence.
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Attributes and Skills:
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High-paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with suppliers & key stakeholders. Strong leadership skills and ability to influence cross-functional teams to drive work scope to completion. Self-starter, bias for action with ability to follow assignment through to completion. Good organization skills. Cross-technology and cross-discipline collaboration skills. Aptitude for systems-level thinking, including development of standard operating procedures. Ability to write structured, concise, unambiguous technical English with high attention to detail. Core understanding of statistical analysis and design of experiment experience.
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Our Global Team:
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We are a team of over 70,000 dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world.
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Benefits:
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As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they face. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
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Our Culture:
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We spark ideas that lead to positive impact and continued success. We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed.