Head of Global Design Assurance Engineering (all genders)

EU; Österreich; Vor Ort; EUR 40 000 - 60 000; Vollzeit

Zusammenfassung

Greiner Bio-One sucht einen erfahrenen Head of Global Design Assurance Engineering, um global Designkontrollprozesse zu optimieren. In dieser Rolle sind Sie für die Qualitätssicherung in der Produktentwicklung verantwortlich, arbeiten in einem internationalen Umfeld und setzen Standards für Produktqualität. Sie bringen über 10 Jahre Erfahrung im Qualitätsengineering, vorzugsweise im medizinischen Bereich, mit.

Leistungen

Attraktive Sozialleistungen

Qualifikationen

• Über 10 Jahre Erfahrung in internationalem Qualitätsengineering.
• Erfahrung im Bereich Medizinprodukte.
• Erfahrung mit FDA-Vorgaben.

Aufgaben

• Leiten und Sicherstellen der Einhaltung von Designkontrollprozessen.
• Zusammenarbeit mit Produktentwicklungsteams.
• Überwachung der rechtzeitigen Durchführung von Designkontrollpflichten.

Kenntnisse

Führungsfähigkeiten

Qualitätsmanagement

Regulatory Compliance

Ausbildung

Bachelor-Abschluss in Lebenswissenschaften oder Ingenieurwesen

Jobbeschreibung

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Job overview

• Immediate start
• EURES flag This EURES flag means that the employer is particularly interested in recruiting workers from other European countries

Working languages: German
Job sector: Manufacture of other chemical products n.e.c.
Work schedule: Full-time
Contract type: Contract to hire

• Direct hire: "Hired directly by the employer, without any external staffing"
• Temporary: "Position only for a certain period"
• Temporary to hire: "Position starting as a temporary job, with the option of a permanent job"
• Contract to hire: "Position starting as a contract job, with the option of a permanent job"
• Contract: "Contract hire"
• Internship: "Work experience offered by an organization for a limited period of time"
• Apprenticeship: "Combines job training with academic education"
• Seasonal: "Temporary and short-term job"
• On call: "Position on an “as needed” basis"
• Recruitment reserve: "Candidate is on the waiting list for the job vacancy"
• Self-employed: "Person pursuing a gainful activity for their own account, under the conditions laid down by national law"
• Volunteer: "Volunteer work"

Number of posts: 1 This job vacancy offers one or more positions of the same type

Deadline: 08/5/2025 8 May 2025

Job details

Job description

Ein Unternehmen des nördlichen Kremstales im Bezirk Kirchdorf an der Krems sucht:

• Head of Global Design Assurance Engineering (all genders)

Location: Kremsmünster, AT, 4550
Frickenhausen, DE, 72636
Travel activity: 30%

Job Type: Permanent

Your Challenge

We are looking for a skilled and driven leader to join our global quality team. As the Head of Global Design Assurance Engineering at Greiner Bio-One International GmbH, you will lead and optimize global design control processes from a Quality Management (QM) perspective. Your primary focus will be to harmonize and continuously improve design assurance practices across our Preanalytics (PA) and Bioscience (BS) business units, ensuring compliance and efficiency for both regulated and non-regulated products.

Your main responsibilities will include:

• Lead and ensure compliance with design control processes across the organization.
• Collaborate with product development teams to promote and maintain the quality of product development projects.
• Oversee the timely completion of design control deliverables for design changes, clinical, and new product development projects.
• Conduct independent reviews of design control projects and changes.
• Define quality plans as part of the design control strategy.
• Review and approve product and material specifications.
• Establish and drive risk management activities in the early stages of product design.

Your profile

• Hold a Bachelor's degree in a relevant life science or engineering discipline.
• Bring over 10 years of experience in international quality engineering, with a strong focus on FDA regulations.
• Have more than a decade of expertise in the medical device sector.
• Possess a deep understanding of leading QM processes and tools.
• Demonstrate proven leadership abilities in managing strategic quality initiatives.
• Showcase autonomy and a proactive approach to your work.
• Previous exposure to global companies and diverse cultures is advantageous.
• Be proficient in English; additional languages are considered a plus.

Office location: Kremsmünster (AT) or Frickenhausen (DE).

Our Offer

We offer you a role in a global QM environment with the opportunity to further develop your existing qualifications. In addition to our many attractive social benefits, the minimum annual salary in Austria is based on employment group IV of the collective agreement for the chemical industry. In other countries, compensation may vary based on local market conditions and legal frameworks.

Contact details: As part of a pre-selection process, please contact the Kirchdorf Public Employment Service (AMS) by phone: Iris Koblinger. I am available for you from Monday to Friday during our opening hours at the phone number 050 904 407 401. When submitting your application, please include the reference number: 16817225. The minimum salary for the position of Head of Global Design Assurance Engineering (all genders) is 4,157.14 EUR gross per month based on full-time employment. Willingness to pay above this amount is expected.

Job location

Employer

Name: Greiner Bio-One, Sector: Manufacture of other chemical products n.e.c., Organization size: Large enterprise

Remuneration

Remuneration basis: Fixed base paid, Salary: From, Up to (Initial rate of compensation)