Job Title: Medical Device Quality Engineer (QE)
Location: Perth (Scotland)
Reports To: Site Quality Manager
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Reporting to the Quality Manager – Microbiology Perth, the QE will be required to investigate the root cause of Quality Notifications (customer complaints) and internal batch failures. With the aim of reducing the overall number of these issues, providing prompt and accurate responses to external and internal customers. Provide technical support to production during investigations and the implementation of corrective actions. The role will entail the prioritization of work to minimize the impact on the business and customers. To be able to work with and coordinate a cross functional team, with the aim of improving overall product quality, reducing scrap and driving down costs and improve quality.
To investigate and report on customer quality notifications and internal batch failures. To coordinate and support Production and Quality Control in identifying root cause and establishing corrective actions. To liaise with Technical support and other functions as required and champion quality within the business. Be an effective leader in promoting quality disciplines, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- To adhere to the Company and departmental Health and Safety policy and guidelines
- To ensure investigations and working being conducted is conducted in a safe and secure manner.
- To report results and investigation findings in a accurate, clear and concise manner
- To complete QN investigation reports and relevant NCR investigations in a timely manner
- Liaise with all functions on site, primarily Manufacturing and Basingstoke technical support & Manufacturing sciences and/or other functions as required.
- To conduct investigations/testing/validation\\ projects or other work as required by the Quality Manager or site leadership team.
- To participate in PMD assessments using defined objectives including those from the site scorecard
- To support and actively participate in the PPI (Continuous improvement) programme, (including Kaizens) within the Company.
- Partner with operations leadership to establish controls and inspection points to facilitate detection, correction and prevention of non-conformating materials or products
- A Bachelor’s degree in science discipline or related field with significant experience in a medical device or pharmaceutical environment.
- Medical device, GMP, EU regulation or ISO 13485 background
- The candidate should have experience of team working and time management and should have strong motivational skills.
- Be a self-starter who can take general concepts and direction and produce desirable results
- Have the ability to use own initiative and cope under pressure
- Have excellent communication (written & verbal) and organisational skills
- Be confident, pro-active, hard working and looking to make a difference
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