Quality Assurance Engineer
Do you want to contribute to the future of healthcare? As Siemens Healthineers values those who dedicate their energy and passion to this cause, our company’s name is dedicated to our employees. It’s their pioneering spirit, blended with our long history of engineering in the ever evolving healthcare industry that truly makes us unique as an employer.
We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone in order to grow both personally and professionally. Sound interesting?
Then come in and join our team as Quality Assurance Engineer to be responsible for maintaining, monitoring and improving key elements of the Quality Management System for the Sudbury Site, including CAPA, internal audits, nonconformance management and document control. You will drive the development of a Quality culture by education, mentoring and example.
Your mission and responsibilities:
Support CAPA process and provide mentoring to ensure timely and accurate completion.
Administer & monitor the deviation process to ensure timely and accurate completion.
Prepare for customer, regulatory & notified body audits. Conduct internal quality audits and produce audit reports.
Control the quality document repository including administration of the change control process. Prepare, review and approve or reject quality related documentation.
Create, issue and archive quality certifications including CofA's & CofC's.
Provide support for training in key aspects of the Quality Management System including Good Documentation Practices, Good Manufacturing Practices, CAPA and Quality Induction training.
Generate quality related metrics, reports and KPI's and lead improvement projects and quality initiatives.
Liaise with Regulatory Affairs providing support for Customer information requests and regulatory application requests.
To find out more about the specific business, have a look at https://www.healthcare.siemens.co.uk/point-of-care-testing
Your qualifications and experiences:
In depth knowledge of Quality Management Systems, MDSAP, ISO13485, 21 CFR820
Knowledge of CAPA process and requirements
Experience of working with non conformance and deviation Management
Document Control within Medical Device Industry
GDP & GMP (Good Documentation Practices & Good Manufacturing Practices)
Being part of our team:
Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Your cultural fit:
Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we want you to seek, implement and celebrate your best ideas.
Job ID: 91441
Organisation: Siemens Healthineers
Experience Level: not defined
Job Type: Full-time