PURPOSE AND SCOPE:

Direct and coordinate activities concerned with production of company product(s). Responsible for training, compliance issues, and maintaining consistency of best practices in the department. Optimizes use of SPC software and evaluating appropriateness of testing based on quality requirements. Supervises Quality Systems Technicians and projects assigned to department.

 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Supervises the daily operations of the team, including but not limited to: establishing mutual goals, assigning tasks and maintaining schedules.Provides direct supervision of the assigned team(s) through ongoing leadership and guidance.Oversees solutions quality control activities including in-process testing and SPC.Develops and implements corrective actions for NC's and CAPA's.Investigates and completes necessary documents for product release.Responsible for purchasing miscellaneous production materials to maintain department GMP.  Oversees that ordered materials are properly placed in the department.Develop plans by conducting analyses; identifying critical process points and preventative measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.Coordinates with Quality engineering to complete required CAPA and NCR documentation.Conducts independent GMP inspections and assign corrective actions.  Initiates work order with various departments as necessary.Develops and assists in all aspects of department training. Participates in department line audits and supports the Quality group with quality improvement projects including CAPA's.Confers with management to gain knowledge of specific work situations to help employees to better understand changes in policies, procedures, regulations, and technologies.Monitors complaint trends and NCR's to identify problems and develops methods and training to make improvements.Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.  Interacts daily with subordinates and/or functional peer groups.  Interaction normally involves the exchange or presentation of factual information.Assist 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.Frequently required to stand; walk; sit and talk or hear. Occasionally required to use hands and fingers, handle or feel; reach with hands and arms; climb or balance; stoop, kneel, or crouch, and wear personal protective equipment that may include safety shoes, safety glasses, hair net, face mask, face shield, solution bunny suit. Must occasionally lift and/or move 10 to 25 pounds.Occasionally exposed to wet and/or humid conditions; moving mechanical parts and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

 

SUPERVISION:

May be responsible for the direct supervision of various levels of solutions support staff.

 

EDUCATION:

Bachelor's Degree required; in lieu of degree additional years of experience and/or education may be considered.

 

EXPERIENCE AND REQUIRED SKILLS:             

2 - 3 years' experience as an individual contributor senior role; or 1 - 3 years' experience as a Supervisor.An understanding of Statistical Process Control (SPC), calibration, the use of test methods and the ability to train personnel on the principals of SPC.Understands the change control system, to include DN's, Validated Systems Changes, and Validation Protocols. Ability to write procedures Computer System Validations (CSV) and submit the change for implementation.Manage and program employee used software systems including but not limited to InfinityQS, Precision Multisensor Metrology Systems, FIFO system, and department labeling software.Advanced knowledge in computer hardware configuration, software integration, and database development.  Understands regulatory and procedure requirements to recognize noncompliance and take appropriate action.Strong oral and written communication skills.Proficient with PCs and Microsoft Office applications.

 

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.

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status.
 
Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.