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Product Risk Manager and Quality Management Specialist - potential for excellent progression

Job Description

Product Risk Manager and Quality Management Specialist (flexible hours)

Siemens Magnet Technology – Oxford

The role:

We have a great opportunity for an experienced Quality Specialist to join our site in Oxford where we design and manufacture superconducting magnets for MRI systems. The role will be responsible for the product risk management by coordinating, directing, controlling, and standardising activities. Furthermore, the role is supporting the management of the QMS by contributing to internal and certification audits. There is an opportunity for progression to Senior Management position within 2 to 3 years. Experience in Product Risk Management is preferred, but not essential as training can be given. If you have not worked in a dedicated Product risk role, you should have extensive knowledge of Quality Management Systems, Quality Assurance or Quality with excellent people leadership skills.   

Your mission and responsibilities:

Embedded Risk Management in the QMS process and projects:

  • Development, documentation and implementation of a consistent Product Risk Management process aligned to ISO 14971.
  • Involvement in development projects with Risk Management teams in Germany and China, and participation in influencing activities towards third parties.
  • Ensure implementation and control of risk management quality gates to gain a sustainable higher quality in the process / projects.
  • Initiate continuous improvement and ensure that all changes requiring Risk Management are correctly executed against ISO 14971/IEC60602/Pressure Equipment Directive (PED).
  • Facilitate methodologies to ensure product designs are appropriately assessed and reflect the customer requirements appropriately to achieve high customer satisfaction / retention.  Shared responsibility.
  • Ownership for ISO 14971 audits, maintaining the UL accreditation and facilitating the 3 Yearly Certification and Annual Surveillance assessments.
Contribution to the maintenance of the QMS certification (ISO 9001) through the three yearly certification program.

  • Lead discussions with the external auditors (e.g. notified body, customer) for dedicated processes during audit.
  • Perform internal audits.
  • Initiate and coordinate risk management / quality management relevant activities to ensure that processes are embedded, followed and continuously improved. 
 Regulatory Support:

  • Assist with the management of product regulatory approval through regulatory bodies and product risk management processes with internal departments (PLM, CRM, SCM & Q).  Manage communication channels to ensure completion of all activities within project timelines.  Ensure all coding risks against both IEC 60601 and the PED are identified, and the correct mitigations and in place to support all coding submissions.
Authorisation:

  • Deputy signatory of the Declaration of Conformity for the PED and other product regulatory declarations as applicable, and regulatory / RM object within changes.
  • Member of the Product Safety Council.

Your qualification and experience:

  • A degree, higher diploma or relevant experience
  • Excellent leadership skills.
  • Experience with design and production processes
  • A good mechanical & electrical appreciation with a bias towards quality/risk management
  • Experience with either Risk Management or QMS or Regulatory Affairs
  • Experience with ISO 9001 Quality Management Systems
  • ISO 9001 internal auditor - preferred

Your skills:

  • Excellent communication and interpersonal skills, possessing the ability to bring a spirit of quality excellence to all employees.
  • Self-assured with external parties and senior management
  • Comprehension of risk management/quality concepts (8D, CAPA, FMEA etc)
  • Skilled in data analysis
  • Excellent planning & organisational skills

Being part of our team:

Siemens Healthineers is a leading global medical technology company that works for people to live longer, more fulfilled, and happier lives. 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.

In Oxford, Siemens Magnet Technology design and manufacture superconducting magnets for MRI systems. We are the global leader in our field, with 30% of the MRI systems around the world containing our superconducting magnets at the heart. Please follow this link for further information about our products and services: https://www.siemens-healthineers.com/en-uk/magnetic-resonance-imaging/siemens-magnet-technology

Benefits:

We offer a comprehensive rewards package which includes:

  • Flexible working hours
  • A competitive salary plus bonus scheme
  • Generous pension contributions
  • 26 days annual holidays
  • Subsidised restaurant and on-site gym
  • Access to our flexible benefits including private healthcare, dental cover, and many more
  • Flexible working hours
  • Corporate Social Responsibility opportunities including 2 paid volunteering days per year

In our rural setting four miles from Oxford, there’s ample parking with strong commuter links to the surrounding area; and a bus stop on our doorstep. In addition, we provide a flexible and dynamic environment with the space to stretch beyond your comfort zone in order to grow both personally and professionally. 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.


Development, documentation and implementation of a consistent Product Risk Management process aligned to ISO 14971.

Organization: Siemens Healthineers

Company: Siemens HC Ltd. MR Magnet Technology

Experience Level: not defined

Job Type: Full-time

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