PURPOSE AND SCOPE:
Conducts Quality audits of products assuring company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems. Functions as an information source to employees when quality issues occur.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures.
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
Works on assignments that are routine in nature; determines whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA.
Analyzes equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional action to resolve the problem needs to be taken.
Assures laboratory equipment and instrumentation is calibrated and properly maintained
Performs operation, including routine maintenance/cleaning for analytical instruments to ensure proper operation.
Documents investigation steps and results.
Communicates with company personnel to investigate complaints.
Follows all policies, guidelines, and Standard Operating Procedures (SOPs) as required.
May refer to senior staff for assistance with day-to-day problems that may arise.
Escalates issues to supervisor for resolution, as deemed necessary.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects as assigned by direct supervisor.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
EDUCATION:
High School Diploma required.
Associate’s Degree or Bachelor’s Degree in Science preferred (Chemistry or Microbiology preferred).
EXPERIENCE AND REQUIRED SKILLS:
Minimum 0 – 1 years of related experience.
Understands basic concepts and principles of dialysis.
Mathematical aptitude required with a good background in algebraic skills and measurement skills.
Basic computer skills with database, spreadsheet, and word-processing programs.
Strong oral and written communication skills.
Strong attention to detail.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
As long as the job advertisement is displayed, you can apply quickly and easily.
We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.