Join us in pioneering breakthroughs in healthcare. For everyone.Everywhere. Sustainably.
Our inspiring and caring environment forms a global community thatcelebrates diversity and individuality. We encourage you to step beyond yourcomfort zone, offering resources and flexibility to foster your professionaland personal growth, all while valuing your unique contributions.
Apply now for the position Quality Systems Engineer and you will ensurecompliance with ISO13485, FDA 21 CFR Part 820 and other international regulatoryrequirements, and ensure business needs are met through the delivery andoperation of vigilance and post market activities, internal and external auditsand CAPA System. This is a home-based role (#LI-REMOTE) with occasional travel to our site in Llanberis.
Your Role:
1. You will provide support for post market activities and representation onvarious product related meetings.
2. You will be responsible for the effectiveness of CAPA, internal/externalaudits, input to Management Review at site level.
3. You will support corporate QM function with site vigilance activities.
4. You will support the site with internal and external investigations/inspectionssuch as FDA, Notified Body, LRQA, RAQS.
5. You should ensure quality system procedures are updated accordingly.
Your Expertise:
6. You will ideally be educated toDegree / Higher National Certificate / Diploma in an Engineering or Scientificsubject.
7. Previousexperience of working in a regulated industry in a scientific / technicalenvironment would be advantageous.
8. Ability toinfluence own and other areas of the organisation to ensure business goals andcompliance expectations are achieved is essential.
9. You are expectedto be able to effectively communicate and work with a variety of personnel atvarious levels within the organisation who have a variety of backgrounds andexperience.
Our Benefits:
10. 26 days'holiday with the option to buy or sell an additional 5
11. Up to 10%employer pension contribution
12. Share and bonusscheme
13. Access to ourflexible benefits from private medical insurance to dental cover
14. CorporateSocial Responsibility opportunities including 2 paid volunteering days per yearand 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 70countries. As a leader in medical technology, we constantly push the boundariesto create better outcomes and experiences for patients, no matter where theylive or what health issues they are facing. Our portfolio is crucial forclinical decision-making and treatment pathways.
How we work:
When you join Siemens Healthineers, you become one in a global team ofscientists, clinicians, developers, researchers, professionals, and skilledspecialists, who believe in each individual’s potential to contribute withdiverse ideas. We are from different backgrounds, cultures, religions,political and/or sexual orientations, and work together, to fight the world’smost threatening diseases and enable access to care, united by one purpose: topioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
As an equal opportunity employer, we welcome applicationsfrom individuals with disabilities.
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To allrecruitment agencies:
Siemens Healthineers' recruitment is internally managed, withexternal support permitted only when a qualified supplier has established aformal contract with us. Unsolicited candidate submissions and referrals,absent a current supplier contract, do not establish consent and are ineligiblefor fees. We delete and destroy unsolicited information, thus, would recommendyou refrain from any such practices. Your adherence to our policies isappreciated.