Quality Systems Technician I

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:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Involves moderately active work involving walking and/or standing for considerable lengths of time. Bending to floor level is required and the employee must be able to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level.

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.