Validation Quality Engineer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Join our team now at Siemens Healthineers Validation Quality Engineer and you will support the Diagnostics business at our manufacturing facility in Llanberis.

Job Responsibilities:

• Ensuring compliance with ISO 13485:2016, ISO14971:2019, FDA 21 CFR Part 820 and other International Regulatory requirements including MDR and IVDR compliance.
• Focused on supporting internal and supplier validation activities and risk management for both In-Vitro diagnostic reagent and instrument manufacturing.
• Working with the validation and engineering teams to ensure quality of validation activities and compliance.
• Support the validation and manufacturing testing organization to ensure rigorous test method validations
• Effective implementation of policies, procedures and practices that are aligned with the company objectives and effective interactions with the leaders and key stakeholders in other functions of the organisation.

Your Skills & Experience:

• Ideally with 2 years + relevant experience in Validation Quality.
• Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics or Mechanical Engineering) OR appropriate and commensurate experience.
• Experience in leading and being a part of teams and projects with strong communications written and verbal.
• Ability to work in technically complex multi discipline areas across the manufacturing site.
• Understanding of quality techniques and best practice relating to: validation, risk management including PRT and pFMEA activities.

Our Benefits:

• 26 days\’ holiday with the option to buy or sell an additional 5
• Up to 10% employer pension contribution
• Share and bonus scheme
• Access to our flexible benefits from private medical insurance to dental cover
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities. Siemens Healthineers are proud to be a Disability Confident Committed employer.If you require any adjustments at any stage of the recruitment process, please let us know.

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