Quality Engineer

Location: Germany

SIRE Life Sciences® ist der Marktführer in der Recruitment-Branche der Life-Science-Industrie. Wir glauben, dass die Recruitment-Branche noch einige Verbesserungen in Technologie und inhaltlicher Innovation vornehmen kann. Wir lieben Technologie und in einem Markt, der auf Life-Science orientiert ist und sich auf den wissenschaftlichen Aspekt konzentriert, können wir nicht zurückbleiben; wir betreiben Recruitment-Wissenschaft. Wir investieren einen großen Teil unseres Umsatzes in Technologie, wodurch wir einzigartige Ressourcentechnologie verwenden können. Durch die Verwendung von hochgradig entwickelten Algorithmen, ist es unserem Team an Ressourcen- & Datenstrategen© möglich, das am meisten ausgebaute, detaillierteste und vollständige Life-Science-Netzwerk in Europa zu erhalten. Durch diese großen Datenmengen (Big Data) ist es uns möglich, Reverse Recruitment© zu betrieben: wir analysieren erst tief gehend den Markt, bevor wir uns in den Markt begeben. Da wir den gesamten Markt analysieren, können wir Fakten und Daten vergleichen. Dadurch können wir Facts & Big Data Recruitment© betrieben, und sicherstellen, dass wir oder besser gesagt, Sie, die besten Karriere finden.

THE COMPANY

is a global Medical Technology company that is focused on enhancing the diagnosis of infectious diseases and cancers, drug delivery, and advancing drug discovery. My client develops, manufactures, and sells medical supplies, devices, laboratory instruments and diagnostic products.

ROLE DESCRIPTION
The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. May support both internal and external audits by assuming the Lead Auditor role. The Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.
RESPONSIBILITIES
Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may lead the investigation/corrective action process.
Responsible for the various aspects of Media QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas. Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, process improvements, and coordination and resolution of CAPAs, OOS’s, Test Methods, product quality notifications, change notifications and customer complaint coordination/closure. This includes using Enterprise tools to ensure compliance and streamline processes.
REQUIREMENTS
- Bachelor's or Master degree with 2 years experience (in a regulated environment)
- Typical degree in Microbiology, Biological Sciences, Chemistry and/or Regulatory Affairs or other related field;
- German and English language skills;
- Six sigma, additionally root cause analysis and project management techniques are routinely employed;
- Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000, ISO 17025 (QC Labs) and ISO 13485:2003;
- Moderate knowledge of QC testing Laboratories and skill to drive root cause analysis of failed tests, test method improvements, and OOS resolution.

Wenn Sie Interesse an dieser Position haben und sich bewerben wollen, füllen Sie das Bewerbungsformular aus, indem Sie auf die Schaltfläche unten drücken oder nehmen Sie Kontakt mit Onno Goedhart auf.