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Danaher Corporation QA Officer in Newcastle Upon Tyne, United Kingdom

QA Officer / QA Specialist

This is a professional position with responsibilities for supporting tasks associated with the site quality system or sub-subsystems. Will follow existing policies, procedures and work instructions to plan and conduct tasks. Will receive instruction and guidance from manager(s) or Sr. QA Officer/Specialist(s). The entry level QA Officer / Specialist will minimally have a college or university degree in science (or equivalent), and the ability perform routine tasks. With experience, the QA Officer/Specialist will work more independently and is expected to apply experience to more complex tasks and problems.

Major Responsibilities

  • Conduct tasks that support one or more areas of the quality system. May include tasks in the following areas:

Quality Systems

  • Conduct tasks in support of NC, CAPA, record management, document controls, training.

  • Review and approve routine batch records. With experience, will identify non-conformances and approve non-routine batch records.

  • Support the organization, planning, hosting, and close-out of audits.

  • Collect and track quality system data and metrics for routine reporting, including Daily Management

  • Other quality system tasks, as assigned

Supplier Quality

  • Support Senior Supplier QA Officer(s) on assigned tasks

  • Conduct tasks in support of supplier audits

  • Collect and track supplier quality data and metrics for routine reporting, including Daily Management

  • Support activities related to quality of incoming materials (iQC)

Premarket QA / Design Assurance / R&D Quality

  • Support Senior Design QA Officer(s) on assigned tasks

  • Conduct tasks in support of Design QA

  • Collect and track design quality data and metrics for routine reporting, including Daily Management

  • Applies general quality and product knowledge to complete assigned tasks. With increasing experience, will apply knowledge to develop and improve processes.

  • Serve as a resource to support senior staff including Senior QA Officer/Specialist(s).

  • Use Danaher Business System (DBS) tools to collect and track metrics.

  • Establish and maintain strong relationships with QA colleagues and wider QRA team.

  • Other duties as assigned by management.

Required Skills/Experience/Education

  • Bachelor’s degree in science, medical or technical field and in Quality Assurance, preferably medical device or IVD.

  • Ability to apply general scientific and quality knowledge to effectively complete assigned tasks.

  • Ability to detect problems and analyze data.

  • Strong organizational skills. Ability to multitask

  • Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.

  • High level of integrity

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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