Sr Quality Engineer - Fresenius Medical Care Holdings, Inc.

PURPOSE AND SCOPE:

Coordinates all efforts for major projects and other significant assignments. Assists in performing disciplined problem solving for supplier, customer, and internal quality defect. Plays an active role in supporting design control activities, concept through release. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Coordinates timely and complete investigations within the assigned manufacturing plant.
• Ensures compliance to all state and Federal regulations and requirements.
• Composes and executes design and process verification and validation protocols and reports. Reviews and approves protocols and reports written by other staff as appropriate.
• Investigates root cause solutions for product release through nonconformance reports (NCR), corrective and preventative actions (CAPA), and material containment and hold forms (MCH) and affected lot hold forms (ALH).
• Utilizes basic statistical techniques, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), and Failure Modes and Effects Analysis (FMEA).  Conducts and interprets Gage Reproducibility and Repeatability (R&R) studies.
• Provides support in coordinating plant risk management activities and ensuring risk management techniques are implemented throughout product lifecycle.
• May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• May manage and execute testing and release procedures for finished products.
• Mentors other staff as applicable.
• 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 a 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:

Bachelor’s Degree required; Advanced Degree desirable.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 5 – 8 years of related experience; or a Master’s degree with 3 years’ experience.
• Strong analytical & troubleshooting skills.
• Ability to understand and employ mathematics at an engineering or scientific level. 
• Strong technical report writing skills.
• Ability to read, analyze, interpret common scientific and technical reports, technical procedures, governmental regulations. 
• Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
• Strong oral and written communication skills.
• Strong computer skills, proficient with Microsoft Office.

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

ADDENDUM:

Engineer/CAPA focus

• Manages the analysis on CAPA trends and other areas of plant quality data on a periodic basis.
• Ensures that the CAPA procedures are clearly defined and implemented to fulfill regulatory and business requirements.  Identifies areas for continuous improvement of these procedures.
• Ensures all CAPA files are maintained.
• Coordinates timely and complete CAPA investigations within the assigned manufacturing plant.     
• Provide direction and guidance to plant employees with CAPA responsibilities.  Lead and train plant personnel on CAPA.
• Maintain current SOP’s related to plant CAPA processes and procedures.
• Analyzes and reports on CAPA trends, and other areas of quality data on a periodic basis. 

Engineer/Quality Management Focus

• Ensures that the Supplier Management procedures are clearly defined and implemented to fulfill regulatory and business requirements.  Identifies areas for continuous improvement of these procedures.
• Ensures all Supplier files are maintained.
• Assist in providing in-house training (e.g., calibration, validations, GDP, in conjunction with plant management to operations and other personnel as assigned.
• Participate as a member of the facility’s Audit Team in performing internal and external audits as required.
• Use appropriate statistical methodology, such as CpK and trend analysis, to assist in analyzing or reviewing manufacturing, quality, and/or laboratory data for recurring problems or the detection of trends.  Establishes reports and procedures in conjunction with Process Engineering to assure system reliability and product quality.  When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution.
• Ensures all CAPA files are maintained.
• Coordinates timely and complete CAPA investigations within the assigned manufacturing plant.     

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