Quality manufacturing Engineer (w/m/d)

The Quality Engineering Team supports Patient Monitoring Products and solutions. We ensure world-wide integrated supply chain process and compliance with all applicable Regulations and requirements.

Our Team is working closely together with a partnership support to our stakeholder in which we apply a very supportive and respectful working style.

Das bieten wir Ihnen

• Attraktives Gehalt und langfristige Jobsicherheit durch Konzernzugehörigkeit
• Umfangreiche Sozialleistungen, inklusive Weihnachts- und Urlaubsgeld
• Urlaubsanspruch von bis zu 30 Tagen Urlaub im Jahr
• Persönliche Beratung mit individueller Karriereplanung
• Weiterbildung durch e.Learning-Angebote
• Monatlich wechselnde Mitarbeiterangebote, z.B. für Technik, Mode, Autos usw.

Ihre Aufgaben

• Responsible together with Change Management for manufacturing changes, production and process controls and Non-Conforming Product Processes to support Process-and Product changes and possible Line down action items.
• Analysis of defects for determining disposition of non-conforming Products/Parts.
• Contribute to Operations performance monitoring, reporting, improvement- and development activities. Support any Factory improvement program for continuous improvement activities.
• Assists other Quality Engineers with their Receiving Inspection or MRB activities, as required.
• Support all existing Team members of the Quality engineering team to ensure Projects and Changes will be done timely according to their schedule.
• Review and comment all deliverables related to changes and/or NPI Projects.
• Consult and accompany changes for Processes- and Products within the factory and responsible for related non-conforming events and investigations.
• Review Deliverables and give feedback on content and compliance.
• Support Material Review board (MRB) activities for non-conforming Products and disposition management as well as support Product Holds.

Ihr Profil

• Engineering degree in a Technical discipline or equivalent professional qualification and experience
• 3-5+ years experience in the medical device sector or similar highly regulated industry
• Knowledge of Standards like ISO13485, ISO14971 21CFR820 paired with pragmatism in application and execution
• Experience with engineering changes and handling of non-conforming products
• Demonstrated effectiveness in independently investigating problems using root cause analysis method and moving them towards resolution
• Organized/structured and creative work approach
• High Product reliability and quality focus
• High engagement, motivation and flexibility
• Sociable Team player with a suitable Cooperative communication style
• Strong English and German communications skills, written and oral
• Experienced in requirements engineering, process validation, change management, Sampling size, Risk management (PFMEA) and design transfer activities.
• Experience working in an international environment
• Strong understanding of best practice quality tools e.g. SAP, Mini Tab, etc.