Quality Manufacturing Engineering Manager (m/f/d)

Philips Healthcare Installation Teams; Böblingen; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen in der Gesundheitsbranche sucht einen Quality Manufacturing Engineering Manager, um die Qualität von Patientenüberwachungsprodukten sicherzustellen. In dieser spannenden Rolle sind Sie für die Einhaltung von Vorschriften, die Unterstützung von Geschäftspartnern und die Leitung eines Teams von Qualitätsingenieuren verantwortlich. Sie werden eng mit verschiedenen Abteilungen zusammenarbeiten, um sicherzustellen, dass alle Produkte den höchsten Qualitätsstandards entsprechen. Wenn Sie eine Leidenschaft für Qualität und Patientenversorgung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Betriebliche Altersvorsorge

Familienservices

Gesundheitsprogramme

Moderne Arbeitszeitmodelle

Work-Life-Balance-Programme

Qualifikationen

• Erfahrung in der Medizintechnik oder anderen regulierten Branchen.
• Kenntnisse in Prozessvalidierung und Auditvorbereitung.

Aufgaben

• Leiten eines Teams von Qualitätsingenieuren und Management von Budgets.
• Interaktion mit verschiedenen Abteilungen zur Gewährleistung der Produktqualität.

Kenntnisse

Prozessvalidierung

Qualitätsmanagementsysteme (QMS)

Auditvorbereitung

Teamführung

Kommunikationsfähigkeiten

Problemlösungsfähigkeiten

Ausbildung

Masterabschluss in einem technischen Fach

Tools

ISO13485

21CFR Part 820

ISO14971

Jobbeschreibung

Job Title:
Quality Manufacturing Engineering Manager (m/f/d)

Job Description:
The Quality Engineering department supports patient monitoring products and solutions. We ensure world-wide product approval and compliance with all applicable Regulations and requirements. Therefore we are looking for a Quality Manufacturing Engineering Manager (m/f/d). As part of the Quality Operations Organization within Royal Philips, your challenge will be to guide and support Business Partners and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products and processes that deliver high quality and outstanding reliability to the lives they will improve.

Your Role

• Interact together with product development, customer services, Risk Management, Industrialization, Product and Operations Management to provide direction and consultation for all Factory and/or Warehouse related to Product & Process Quality.
• Manage a team of Quality Manufacturing engineers, including Budget, Goals, Performance management, Prioritization, capability development and talent management activities.
• Regularly interact with management levels on matters concerning several functional areas and/or customers for the local Quality Manufacturing Area.
• Involved in developing, modifying, and executing company policies and Quality Monitoring meetings that affect Operations and may also have company-wide effect.
• Report out proactively on all relevant KPIs and manage those when deviations occur and initiate proper corrective- and preventive actions and participate in daily management meetings.
• Create Product- and Process Quality awareness level as determined within the organization especially the integrated supply chain.
• Enforce (a simplified) quality systems and harmonize them across the HPM Sites and support an effective Management Review process, including routine reporting.
• Manage internal and external Audits and compliance to FDA regulations and other Regulatory Agencies as required, ensuring guidelines and policies to all products and operations are consistent with those regulations.
• Manage the review and approval of finished products manufactured in accordance with their approved specifications and regulations as well as manage product recalls.
• Interact with other global functions together on a corporate company level for all upcoming Programs and Projects.
• Up to 10% of your time working operationally to support QME Projects NPI/MLD.

You're The Right Fit If

• Master’s degree in a technical discipline and practical experience as an engineer in a regulated industry like medical devices or Pharma.
• Experience in the Medical Device Industry or other regulated industry as a leading Project Engineer, Manager or Team lead to lead Teams and Team members individually and situation-related.
• Experienced as a former Engineer (preferably Quality) with knowledge of Process Validation, NC handling, Hold, Environmental control, Calibration, Preventive maintenance, Audit preparation, QMS Procedures.
• Ability to positively influence the Team and/or stakeholders to do the right thing for Patient Safety and Quality, or gain acceptance from others in sensitive situations, without impacting the relationship or Business.
• A sociable and supportive character to coach all team members to drive a high level of professionalism within the engineering group with a Cooperative communication style and hands-on mentality.
• Knowledge of Standards like ISO13485, 21CFR Part 820, ISO14971 paired with experienced pragmatism in application and execution.
• Experience with internal and external Audits and follow-ups, handling of non-conforming Products combined with disposition activities as well as Corrective- and Preventive Actions (CAPA).
• Organized, well-structured, and creative working style to efficiently lead a team and team up with stakeholders.
• High focus on Production process reliability and quality testing for Medical Devices.
• Strong English and German communication skills, written and verbal.
• Wide-ranging experience, using professional concepts and company objectives to resolve complex issues and conflicts in creative and effective ways.
• Skills in moderating Team Meetings to come to a final conclusion or a concrete next step.

In return, we offer you

Working in the medical industry brings fulfillment, as well as unique challenges. As part of our HealthTech company, you will be responsible for successfully managing Philips relationships with different stakeholders. A person who is excited by new challenges, has strong technical competencies, and demonstrates resilience is most likely to succeed in these challenging, often demanding situations. By taking pride in all you do and inspiring others around you to prioritize Quality and Integrity above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters. We offer you as part of our "Employer of Choice" program company pension scheme, family services, health program, modern working time models and work environment, work-life balance program.

How We Work Together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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