Quality Operations Lead
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 Operations Lead to be responsible for the supervision of the Quality Operations team and maintaining, monitoring and improving key elements of the Quality Management System (QMS) for the Sudbury Site, developing a culture of Quality by education, mentoring and example.
Your mission and responsibilities:
Supervision of the Quality Operations Team
Provide support to the manufacturing operations team
Administer & monitor CAPA & Issue Resolution to ensure timely and accurate completion. Provide mentoring to support the CAPA process.
Administer & monitor the deviation process to ensure timely and accurate completion.
Administer & monitor the QN process to ensure timely and accurate completion.
Prepare for customer, regulatory &
notified body audits.
Conduct internal quality audits and audit reports.
Provide support for training in key aspects of the Quality Management System.
Generate quality related metrics, reports and KPI's and lead improvement projects and quality initiatives.
Liase 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, ISO 13485, 21 CFR 820
Knowledge of CAPA requirements
GDP & GMP (Good Documentation Practices & Good Manufacturing Practices)
Good working experience of Quality Systems and their operational implementation
Supervisory skills would be an advantage but training will be provided
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: 93681
Organisation: Siemens Healthineers
Experience Level: not defined
Job Type: Full-time