Manager Quality Systems & Compliance (m/w/d)

Reposted 8 Days Ago
Be an Early Applicant
Saalfeld, Thüringen, DEU
In-Office
Senior level
Healthtech • Other
The Role
The Manager Quality Systems & Compliance ensures compliance and maintains quality management processes, manages audit systems, oversees IT applications processes, and leads small teams in a healthcare environment.
Summary Generated by Built In

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Baxter Medical Systems ermöglicht Spitzenleistungen bei chirurgischen Verfahren in der modernen Medizintechnik. Von der Notfallversorgung bis hin zur Intensivpflege helfen unsere Produkte den Pflegeteams, hervorragende Ergebnisse zu erzielen. Damit chirurgisches Personal und interdisziplinäre Pflegeteams effizient arbeiten können, sind digitale Systeme und automatisierte Geräte unerlässlich, um Prozesse zu rationalisieren, den Benutzerkomfort zu erhöhen und die Patientensicherheit zu verbessern. Baxter trägt dieser Entwicklung Rechnung und setzt mit seinen intelligenten und vernetzten Lösungen neue Maßstäbe.

Für unseren Standort Saalfeld (Thüringen) suchen wir Sie als Manager Quality Systems & Compliance (m/w/d).

Ihre Aufgabe

  • Sicherstellung der Konformität (Compliance) und der Prozesse zur Einführung, Realisierung und Aufrechterhaltung des Qualitätsmanagementsystems (Quality Systems) unter Berücksichtigung des Baxter Qualitätsmanagementhandbuch

  • Verantwortlich für einzelne Elemente des Qualitätsmanagementsystems (internes & externes Audit- und Auditorenmanagement, CAPA, Training, Dokumentenmanagement und Change Control Management

  • Überwachung der qualitätsseitigen IT Applications-Prozesse (z. B. SAP)

  • Bereich organisieren und optimieren nach Zielvorgaben

  • Monitoring der Kosten im Bereich

  • Qualität des Bereiches sicherstellen

  • Erste Mitarbeiterführung von kleineren Teams

Ihr Profil

  • Ausbildung: mindestens 4-jährige abgeschlossene Hochschulausbildung im technischen oder medizintechnischen Bereich (idealerweise mit Fokus auf Qualitätsmanagement)

  • Berufserfahrung: Langjährige Berufserfahrung im Bereich Qualitätsmanagement (>5 Jahre)

  • Verhandlungssichere Englisch- und Deutschkenntnisse

  • Erfahrung in der Arbeit mit vielfältigen Kulturen und Mitarbeitern

  • Anwendungssichere Kenntnisse im Umgang mit regulatorischen Anforderungen und Qualitätssystemanforderungen der Medizintechnik (EN ISO 13485, EU MDR)

  • Erfahrungen im Auditmanagement

  • Erfahrungen im Umgang mit SAP

  • Sicheres Auftreten, Durchsetzungsvermögen und selbstständige Arbeitsweise

Ihre Bewerbung

Bitte bewerben Sie sich unter Angabe Ihrer Entgeltvorstellungen und des frühestmöglichen Eintrittstermins. Als international tätiges Unternehmen bieten wir Ihnen interessante berufliche Perspektiven, ein kooperatives Arbeitsumfeld sowie ein leistungsorientiertes Entgelt. Genießen Sie die Vorzüge flexibler Arbeitszeitmodelle sowie unsere Programme zur Weiterbildung, Gesundheitsförderung und betrieblichen Altersvorsorge.

Noch Fragen?

Bei Rückfragen steht Ihnen [email protected] aus unserem Talent Acquisition Team gerne zur Verfügung.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.  

#IND-DACH

#LI-SL1

Karrierechancen in Saalfeld entdecken

Sie suchen mehr als nur einen Job? An unserem Standort in Saalfeld hat Ihre Arbeit echten Wert.

Wir sind von Innovation geprägt und bieten eine große Vielfalt an Positionen, in denen Sie wachsen, Sinn finden und zu etwas Bedeutungsvollem beitragen können.

Auf unserer neuen Karriereseite für Saalfeld erfahren Sie mehr darüber, was wir tun, welche Möglichkeiten es gibt und was unser Team so besonders macht.

👉 Jetzt unsere Saalfeld-Karriereseite besuchen: https://bit.ly/41UlcNC 

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Skills Required

  • 4 years higher education in technical or medical technology
  • 5+ years experience in quality management
  • Fluent in English and German
  • Knowledge of regulatory requirements for medical technology (EN ISO 13485, EU MDR)
  • Experience in audit management
  • Familiarity with SAP
  • Ability to lead small teams

Baxter International Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Baxter International Inc. and has not been reviewed or approved by Baxter International Inc..

  • Healthcare Strength Health coverage begins on day one and includes medical, dental, and company-paid life and disability, indicating robust protection. This breadth of coverage is positioned as a strong component of the total rewards package.
  • Retirement Support A 401(k) with company match and related retirement programs support long-term savings. An additional savings infrastructure enhances overall financial security for many roles.
  • Leave & Time Off Breadth PTO scales with tenure and is complemented by paid holidays and meaningful paid parental leave. The scope of time-off programs contributes to a well-rounded benefits offering.

Baxter International Inc. Insights

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The Company
HQ: Deerfield, IL
35,858 Employees
Year Founded: 1931

What We Do

Every day, millions of patients, caregivers and providers around the world rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, kidney care, hospital and surgical products and solutions. For 90 years, we’ve been making an impact at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, therapies and digital health solutions available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. We welcome Hillrom to Baxter, where we are uniting to advance patient care worldwide. We’re building on the strengths of two historically innovative and socially responsible companies that will better serve our patients, customers and communities.

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