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Fresenius Medical Care

Operates dialysis facilities and renal care

Laboratory Manager - Physikalisches Zentrallabor

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeSankt Wendel, GermanyNo salary listedIn-person

About the Job

Requirements

  • An engineering or natural-sciences degree, or a technician qualification with several years of professional experience in a regulated environment.
  • Knowledge of pharmaceutical products and medical devices, including GMP and ISO 13485.
  • Further training in quality management.
  • Experience qualifying inspection and measurement equipment.
  • Ability to monitor and implement data-integrity requirements within the area of responsibility.
  • Knowledge of computer-based measurement systems and an affinity for laboratory information technology.
  • Further training in laboratory occupational safety.
  • Experience in a quality-control laboratory in a regulated environment.
  • Good spoken and written English.
  • Knowledge of common software tools such as LIMS, SAP, and QTRAK.
  • Knowledge of hemodialysis and peritoneal dialysis products, including membrane manufacturing, plastics technology, and dialyzer production.
  • Assertiveness.
  • Technical understanding.

Responsibilities

  • Provide technical and disciplinary leadership for the laboratory.
  • Create and approve standard operating procedures and test instructions to ensure the quality of products manufactured at production sites.
  • Conduct internal and external audits.
  • Oversee maintenance, premises, and equipment in the department.
  • Manage laboratory-focused projects involving analytics, LIMS systems, and test and measurement methods.
  • Manage projects focused on regulatory compliance with international regulations.
  • Coordinate the laboratory’s execution of final inspections, in-process inspections, and incoming-goods inspections.
  • Ensure validation of test methods in the physical central laboratory.
  • Ensure monitoring of test equipment in the physical central laboratory.
  • Continuously develop the area of responsibility and improve its efficiency.
  • Develop new methods, procedures, and test equipment.
  • Participate in cross-departmental projects involving quality assurance, quality, quality software, and organization.
  • Conduct training and document training activities.
  • Supervise and instruct external contractors performing maintenance and cleaning.
  • Take responsibility for LIMS, LabX, and laboratory climate-monitoring systems.

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size
11-50
Company stage
Late Stage VC
Total funding
$40.2M
Headquarters
Waltham, MA
Founded
1996

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