PURPOSE AND SCOPE:

Supports Operations Quality Control manager and Quality Engineers providing assistance in performing disciplined problem solving for supplier, customer, and internal quality defect. Maintains knowledge of all products, processes, and basic quality principles required to assist with daily operations and continual improvement activities. Understands the technical aspects of the company including supplier products and processes in order to drive quality improvements and corrective actions.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Under general supervision and by following established company policies and procedures, assists the QualityEngineer with the analysisand overview of the manufacturing processes performance and support during the root cause analysis investigations.
• Familiar with quality improvement tools and other various qualitytechniques.
• Provides support to all departments regarding product quality, inspections, deviations and disposition of non-conforming product.
• Recommends measures necessary to prevent a recurrence of defects to manufacturing, engineering, supply chain and other departments as needed.
• Analyzes reports anddata in support of in-houseprocess improvements,corrections, and corrective actions as a means of continual improvement.
• Assist the manufacturing area in product transfers, changes and documentation when required
• Self-motivatedto improve knowledge related to quality projects and material issues through training and continuous assessment of current publications, standards and regulations.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Assist 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.
• Ability to lift up to 50 lbs. as required.
• The employee may also be exposed to bovine and human blood products. Hepatitis B Vaccination is recommended.

EDUCATION:

• High School Diploma required; Bachelor’s Degree desired.

EXPERIENCE AND REQUIRED SKILLS:

• 1 – 2 years’ related experience in quality and manufacturing process.
• Minimum one year of experience in similar areas of quality engineering assurance for manufacturing process (Medical Device preferred).
• Must have good technical and analytical skills.
• Strong oral and written communication skills.
• Strong computer skills, proficient with Microsoft Office, SAP.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.