Quality Engineer (m/f/d) für Frankfurt am Main gesucht

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Job Kategorie: Medizin/Pharma/Biotech Qualitätsmanagement (Produkt, Prozess, Kontrolle etc.)

Stellenangebot Basisdaten

Arbeitsort:: DE 65929 Frankfurt am Main
Umkreis:: keine Angabe.
Art der Arbeitsstelle:
Letze Aktualisierung:: 27.12.20242024-12-27

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Stellenausschreibung: Quality Engineer (m/f/d)

Arbeitgeber bzw. Arbeitsvermittler: GULP Information Services GmbH in Mannheim

Branche: Medizin/Pharma/Biotech

Kategorie: Qualitätsmanagement (Produkt, Prozess, Kontrolle etc.)

Stellenbeschreibung: If you are thinking about a new career start, then we should talk! A business partner of Randstad professional solutions from the pharmaceutical industry currently has an exciting position as Senior Quality Engineer in Frankfurt. A variety of tasks, a working atmosphere characterised by appreciation and attractive benefits await you - all in a permanent position directly with the client. Sounds good? We look forward to receiving your online application. Equal opportunities are very important to us - applicants with a disability are very welcome! Das dürfen Sie erwarten - Direct recruitment into a permanent position at our customer - Salary structure depending on qualifications and professional experience - Possibility for mobile working on 3 days of the week - Numerous direct contacts with personnel decision-makers - Appreciative and trustworthy support during the entire placement process Ihre Aufgaben - Accountable for DHF oversight and maintenance for the post-launch stage in collaboration with the global device unit design center - Ensure DHF maintenance procedures and relevant processes are robust, standardized, and adequately maintained following regulatory requirements and best practices - Create and maintain all DHFs structure according to defined process and system in coordination with project teams accountable for new product development or design change projects - Support audits or inspections requiring access to DHFs - Perform DHF reviewsaudits as required to support Design Reviews, audit preparations or part of continuous improvement activities related to DHF maintenance process - Lead DHF remediation efforts - Lead continuous improvement projects or activities which may include product or process improvements and remediation efforts (ie DHF, Risk Management Files, etc.) - Contributing to network forums to support for aligned process execution in the different networks - Coordinating the Device & Packaging Change Board for GDPU and change control communication within the network - Supporting the assessment for network impact and design consistency (e.g. DHF/DMR, Alliance impact etc.) for inter-site change controls between GDPU and network sites - Act as the Single Point of Contact (SPOC) for manufacturing sites of medical devices or combination products for device related Change Controls topics and operational knowledge transfer - Provide mentoring support to Quality Engineers, as instructed by the Manager - Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results Unsere Anforderungen - MS degree in Engineering or related science discipline - An advanced degree is a plus - Relevant experience (5 years+) in the medical device industry - Knowledge of Six Sigma Tools or Six Sigma Green Belt certification is highly preferred - Excellent knowledge of relevant regulatory requirements related to medical devices, drug-device-combination products as per e.g. 21 CFR 820, ISO 13485, EU Medical Device Regulation, ISO 14971, ISO 10993 - Certified Quality Engineering – ASQ certification preferred (CQE) - Good communication and presentation skills toward colleagues and international external partners - Good knowledge of project management and problem-solving/troubleshooting methodologies (GPS) are an advantage - Business fluent in English (written and oral), any other language as a plus

Qualifikation: Arbeitskräfte

Verdienst:: 32767.00 - 32767.00 EUR

Bewerbung an: GULP Information Services GmbH
P7 5-7
De 68161 Mannheim
Telefon: +49 1525 4507336
Email: fiona.krafft2@randstad.de

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