Fresenius Medical Center Sr. Quality Systems Process Analyst in Irving, Texas

PURPOSE AND SCOPE:

Responsible for record review, data analysis/entry, technical writing, aspects of database maintenance, and other related quality data analysis and review activities at the Manufacturing Plant.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Responsible for representing quality team to present data during site, divisional, and corporate level data analysis meetings and QS management reviews.

  • Plans and conducts training sessions, based on emerging trends in the data, to prevent reoccurrence of problems.

  • Updates internal control and audit plans, based on emerging trends in the data and corrective action plans, to assure that current issues are addressed by the internal audit team.

  • Analyzes process sequence and interactions using basic analytical and quality tools.

  • Assists in developing process control and response plans. Assists in training and otherwise communicating changes to process control planning.

  • Updates procedures based on process changes; assist in the creation of documentation for new or significantly changed processes.

  • Maintains files and logs associated with complaints and potentially corrective/preventive action planning to assure timely closure and evaluation of effectiveness.

  • Reviews Device History Records (DHRs), Material Inspection Reports, Monthly test results (environmental, water system, component or process monitoring, etc.), for non-compliance events and trends in the data.

  • Works cross-functionally to back-up, Document Coordinator, and other QS jobs as directed.

  • Participates in planning, writing, and performing process/equipment validations and recording data and completing records for these validations.

  • Assist in the performance of plant investigations into product complaints and prepares reports for review by Quality Management prior to submittal to Corporate Quality Systems.

  • Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.

  • Builds productive working relationships with contacts within own department and external to own organizations (includes contact with outside vendors or suppliers).

  • Assist in risk assessments related to NCRs and document change control process.

  • May assist in audits as a process SME.

  • Review Document Control procedures to identify proficiencies in record and document control management

  • May provide assistance to lower level staff with more general support tasks that require a better understanding of functions, as directed by immediate supervisor.

  • 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.

EDUCATION :

  • Bachelor’s Degree required in Science/Engineering required.

EXPERIENCE AND REQUIRED SKILLS:

  • 2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience.

  • Related laboratory or manufacturing environment experience with experience in cGMP/QSR.

  • Maintenance of Relevant experience with production, inspection, laboratory, and/or documentation control processes sufficient to understand, support, and train as a backup to one or more of those functions. Auditing experience is a plus. As applicable, knowledge of Health Canada GMPs.

  • Experience in creation and execution of action plans.

  • Good organizational skills and ability to multi-task and work with little supervision.

  • Strong interpersonal skills related to conducting failure/complaint investigations; experience with structured problem solving and fact-based decision making tools.

  • Ability to exercise good judgment.

  • Knowledge of basic quality tools for problem definition, data analysis, solution implementation (PDCA), and control planning; exposure to statistical techniques for monitoring quality trends.

  • Awareness of basic continual improvement philosophies such as Six Sigma, Lean manufacturing, or similar programs. Experience in regulatory concepts such as CAPA, non-conformance reporting, and out-of-specification reporting.

  • Familiarity with word processing, spreadsheet, database, and presentation applications (MS Office preferred). Process and data analysis requires familiarity with applications such as flowcharts (Visio) and statistical analysis (Minitab). Ability to quickly learn and adapt to special applications is desirable.

  • Good verbal and written communication skills are required. Oral presentations and writing technical reports are a job expectation.

  • Experience with qualification/validation documents is a plus.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity