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Danaher Corporation Senior QA Officer in Newcastle Upon Tyne, United Kingdom

Major Responsibilities• Responsible for planning, organizing and conducting duties related to assigned element of the site quality system. May include one or more of the following areas:• Quality Systemso Establish and maintain quality system to meet all applicable requirements for medical device/IVD business, e.g. 21 CFR 820 and ISO 13485o Auditso Non conformanceso CAPAo Validationo Batch releaseo Trainingo Quality agreementso Record management and document control• Supplier qualityo Work with procurement on supplier quality standards, supplier quality agreements, metricso Supplier auditso Ensure quality of incoming materials• Premarket QA / Design Assurance / R&D Qualityo QA representative for Design Controls and Risk Management for new product development projects and device change initiativeso Support design quality assurance for cross-site project• Utilize knowledge and experience to identify, solve and document problems and risks within the quality system.• Serve as a resource and mentor to colleagues with less experience, including QA Officers.• Use Danaher Business System (DBS) tools on a regular basis to continually improve the QA function.• Work closely with QRA management in developing quality objectives.• Establish and maintain strong relationships with internal and external stakeholders.• Maintain working knowledge of relevant regulations and quality system requirements that affect the business.• Other duties as assigned by management.Required Skills/Experience/Education• Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance, or• Graduate degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance.• Experience in the IVD field preferred experience very beneficial• Must have requisite training or certification in medical device Quality Assurance through on-the-job training, seminars, training. Relevant certifications preferred.• Depending on assigned area:o Experience conducting and hosting quality system audits.o Extensive knowledge of medical device quality systems including but not limited to 21 CFR 820 and ISO 13485. Strong working knowledge of medical device design controls.o Experience in medical device Design Controls and Risk Managemento Experience in supplier quality, manufacturing, supplier risk management, design transfer processesCompetencies• Ability to apply practical QA experience and knowledge to one or more area(s) of quality assurance.• Ability to identify, analyze and mitigate risk (e.g. product, material, compliance, supply)• Ability to work independently• Strong organizational skills. Ability to multitask• Strong communication skills. Ability to explain difficult or sensitive information. Works to build consensus.• Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.• High level of integrityAdditional Health and Safety Responsibilities• Provide so far as is reasonably practicable a healthy and safe workplace for employees, contractors, and visitors• Support EHS framework and assist in annual planning, implementation, evaluation, and review• Work with EHS Manager to implement policies, procedures, and support improvements• Support best practice safety performance levels and ensure business complies with all relevant EHS regulations• Be actively involved in Workplace Inspections and Near Miss and Incident reporting• Discuss and review statistical data (near misses, incident reports, etc) at monthly management meetingsEnsure safety performance is included in annual staff reviews

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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