Quality Systems Engineer (m/f/d)
KARL STORZ Endoscopy America, Inc.
We are seeking an experienced to be part of our small QA team reporting directly to the Quality Manager. This is a full time permanent role. Based in Slough, although we can consider a hybrid working arrangement with a minimum of 3 days in the office.
Qualifications, skills and experience must include:
CAPA - Acting as CAPA lead, investigate and identify actions for improvement within the QMS. Create and review SOPs and Work Instructions In-depth working knowledge of ISO 13485:2016 and experience of auditing and assessing to medical device standards and regulations Suppliers – manage supplier selection and evaluation processes including re-evaluations and supplier complaints Maintain working knowledge of Regulatory and Quality System requirements eg (ISO 13485, MDR/MDD) Experience in implementation, management and improvement of Quality System processes Ideally, educated to degree level in LifeScience / Engineering, or equivalent through experience Your Benefits Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required 30 vacation days and various special payments Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more Corporate benefits and bicycle leasing Subsidy for private pension plan and company health management Various childcare options – at the headquarters in Tuttlingen Health, sports, cultural and leisure activities – offers vary depending on location
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