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Quality Manager (m/w) Health Care / Medical Devices

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Unser Kunde produziert pharmazeutische Spendesysteme, die eine genaue Dosierung und ein ergonomisches Design für die medizinische Versorgung sicherstellen. Am Standort im Großraum Freiburg sind ca. 600 MitarbeiterInnen in der Produktion beschäftigt. Zu den Kerntechnologien gehört die Verarbeitung thermoplastischer Kunststoffe im Spritzgießverfahren sowie die vollautomatische Montage unter Reinraumbedingungen.


  • Plan, coordinate and manage through completion, assigned projects designed to ensure continuous production and distribution of products consistent with established standards.
  • Lead and supervise the activities of Quality staff.
  • Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures and standards.
  • Duties and responsibilities are accomplished personally or through subordinate staff.


  • Coordinate and execute objectives throughout the company in cooperation with other managers, to maximize product quality and operating system efficiency/effectiveness to minimize costs, in alignment with Quality strategy.
  • Identify and coordinate resolution of system(s) inefficiencies that contribute to increased quality costs.
  • Coordinate the execution of validations, including creation of written protocols.
  • Coordinate the execution and participates in elements of investigations regarding customer complaints.
  • Assesses results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, ISO and Customer requirements.
  • Ensures CAPA system is effective and utilizes problem solving techniques to reduce internal and external failures. Ensures sound techniques are applied (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively. Assesses results for application, validity and conformance to specifications.
  • Analyzes data in relationship to assigned projects to determine adequacy of present standards and establish proposed quality improvements. This includes analysis of current inspection methods and sample plans.
  • Plans, promotes, performs and organizes training activities for internal departments and customers, related to quality activities which include basic statistics, DOE, GR&R, Sample Plan designation; validation creation, control and oversight.
  • Interacts with customers to assure mutual interpretation of specified requirements to ensure fulfillment of customer requirements and objectives are met.
  • Ensures ISO and FDA QSR quality systems compliance.
  • Generates and provides monthly and weekly reports as required.
  • Management of internal and external audit
  • Executes specific responsibilities as defined within the company quality operating system (e.g. Q manual, GMP procedures etc).
  • Supports and maintains all policies of the company including but not limited to applicable FDA regulatory
  • Responsible for budget and investment planning of Q department

KEY ACCOUNTABILITIES (Leadership and team management):

  • Lead the Quality team.
  • Performance management of team (objective setting, results monitoring, support as needed etc).
  • Drive and support development of individual team members
  • Promote a constructive and performance-oriented team culture
  • Be an active and visible member of the plant leadership team (PLT)


  • Experience within the quality profession, Medical Device or plastics industry experience preferred.
  • Six-sigma black belt experience and training preferred.
  • Ability to apply advanced mathematical concepts and intermediate statistical knowledge.
  • Auditor or PM experience in a GMP environment preferred.
  • Excellent communication and organizational skills with proven leadership experience.
  • Experience of having led a larger Q department with international customer and supplier relations incl. ability to understand and articulate how individual role interrelates with Quality department function, goals and objectives.
  • Highly proactive attitude and willingness to travel.
  • German and English language skills
  • Familiar with SAP; ISO 13485.

Specific details

Industry Medizintechnik
Duration > 6 Monate
ZIP area 7xxxx
Project Start sofort

Advert details

Advert ID: 271
Displayed: 536
Expires: 03.07.2020

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