Philips
Supplier Development Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Hamburg
ab 103.510,62 - 138.014,16 / Jahr
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Conducting external supplier audits for medical device components, products, and services, evaluating QMS against ISO 13485 and ISO 9001. 7+ years with Master's or 10+ years with Bachelor's in Quality/Safety/Process Engineering required. 30 days annual leave, subsidized Germany ticket, and car leasing options.
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Anforderungen
- 10+ years experience with bachelor's OR 7+ years with master's in Quality/Safety/Process Engineering or Continuous Improvement
- Demonstrated experience conducting external supplier audits in medical device industry
- Formal training in ISO 13485 and ISO 9001 (minimum)
- Proficiency with audit management systems and documentation tools
- Strong understanding of medical device QMS, supplier controls, regulatory expectations
- Ability to assess complex manufacturing and quality processes
- Excellent communication, negotiation, and relationship building skills
- Bachelor's degree in engineering science, Supply Chain Management, Electrical or Electronic Engineering
- Certified Lead Auditor through recognized program or approved internal training
- Strong attention to detail, analytical thinking, sound professional judgment
- Proven ability to work independently to manage multiple audits
- Interest in role even with partial experience
Aufgaben
- Conduct external supplier audits for medical device components, products, and services
- Evaluate supplier Quality Management Systems (QMS)
- Ensure supply base maintains robust, compliant, and effective QMS
- Align QMS with ISO 13485, ISO 9001, and applicable regulatory requirements
- Evaluate supplier processes
- Identify supplier risks
- Drive corrective action with suppliers
- Support supplier qualification and requalification activities
- Develop audit plans and agendas for external suppliers
- Prepare audit documentation
- Lead remote and on-site audits of supplier QMS
- Assess compliance with ISO 13485 and ISO 9001
- Evaluate manufacturing controls
- Evaluate process validation
- Evaluate risk management
- Prepare comprehensive audit reports detailing findings and recommendations
- Communicate audit outcomes to suppliers and internal stakeholders
- Manage corrective action plans to resolve nonconformities
- Maintain current knowledge of regulatory expectations and QMS standard revisions
- Complete necessary training and requalification activities
- Serve as a subject matter expert for supplier audit practices
- Contribute to ongoing improvements within the audit program
Berufserfahrung
7 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
ISO 13485ISO 9001ISO 17025audit management systemsdocumentation tools
Benefits
Mehr Urlaubstage
- 30 days annual leave
Öffi Tickets
- Subsidized Germany ticket
Firmenfahrrad
- Bicycle leasing
Firmenwagen
- Car leasing
Moderne Technikausstattung
- Smartphone leasing
Weiterbildungsangebote
- Professional training courses
- Personal development programs
Betriebliche Altersvorsorge
- Employer-funded pension plan
Großzügige Elternzeit
- Two paid weeks off for new parents
Mitarbeiterrabatte
- Discount on Philips products
Snacks & Getränke
- Free drinks
Gratis oder Vergünstigte Mahlzeiten
- Low-priced canteen
Lockere Unternehmenskultur
- Informal culture
Sinnstiftende Arbeit
- Paid day for voluntary work
Team Events & Ausflüge
- Team activities
- Cultural activities
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Philips erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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