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Senior product delivery specialist

Dublin
beBeeQuality Assurance
Posted: 11 August
Offer description

As a Senior Quality Assurance Professional, 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 key responsibilities will include acting as a liaison and knowledge transfer champion among supplier quality, quality assurance, manufacturing engineering, R&D, production, and documentation control. You will assess suppliers' capability to meet quality requirements based on data analysis and supplier audit, and create concise reports that enable project teams to implement improvements and corrective actions. Additionally, you will use statistical analysis to support suppliers and drive regulatory standards of excellence. You will develop world-class supply chain processes to suit a low-volume, high-complexity multi-technology environment (diagnostic instrumentation). You will work with suppliers in a wide range of quality-relevant areas such as first articles, general quality, and regulatory requirements. You will also work with suppliers on corrective and preventive actions, root cause investigations, conduct supplier performance reviews, and report key supplier quality metrics. To find out more about the specific business, please have a look at Siemens Healthineers' website.


Job Description



* Act as a liaison and knowledge transfer champion among supplier quality, quality assurance, manufacturing engineering, R&D, production, and documentation control.
* Assess suppliers' capability to meet quality requirements based on data analysis and supplier audit.
* Create concise reports that enable project teams to implement improvements and corrective actions.


Required Skills and Qualifications



* Proven experience in medical devices QMS to develop world-class supply chain processes to suit a low-volume, high-complexity multi-technology environment (diagnostic instrumentation).
* Have led projects to manage suppliers to deliver quality products to internal customers through product & process investigations & evaluations.
* Identified and driven process improvements with suppliers.
* Minimum of a Bachelor's degree in a relevant technical discipline (ideally quality, engineering, or science).
* 8 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and risk management incl. writing and/or reviewing quality-related procedures, plans, and reports.


Benefits



* High-paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with suppliers and key stakeholders.
* Strong leadership skills and ability to influence cross-functional teams to drive workscope 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.
* Familiar with statistical software packages e.g., Minitab.
* Computer literacy (including MS Word/Excel/PowerPoint/MS Project) and interface to product lifecycle tools such as SAP, Teamcenter, or other.
* Presentation skills whereby complex messages can be presented to an auditor/inspector in a succinct manner i.e., ability to present and sell convincingly.


Others



* Our global team comprises more than 70,000 highly 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.
* We are a leader in the industry, aspiring to create better outcomes and experiences for patients no matter where they live or what health issues they are facing.
* 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.

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