PURPOSE AND SCOPE:

Manages and oversees Quality Operations at the facility. Ensures in-process quality controls conform to company requirements and to all applicable state, federal, and international regulations. Ensures that calibration of equipment and instruments conform to their use. Ensures quality of software/process validations and their respective integration with calibration. Ensures Risk Management program at facility conforms to company requirements and all applicable regulations. Ensures the product release meets requirements and specifications. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
• Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.
• Manages the budget for Quality Operations and stays within the approved budget target. Responsible for preparing and managing the budget for the Quality Department.
• Oversees the Risk Management Program and serves as Risk Management Manager for the facility. Serves as Validation Committee Chairperson. Acts as independent reviewer for design control activities, as assigned. Responsible for assigning designates for these responsibilities.
• Ensures risk management activities, process qualifications, and validations are appropriately performed and documented. Maintains knowledge of pre and post production quality planning, monitoring /trending, and internal audits.
• Ensures risk evaluations and risk reviews are performed in a timely manner and the risk management documents are updated accordingly. Ensures process changes are evaluated for impact on product and associated risk controls.
• Ensures the development and maintenance of data collection and analysis systems. Ensures the development, rationale, and review of process and product specifications, and sampling plans.
• Creates quality records in the form of reports and oversees the creation of inspection records, specifications and other reports and communications.
• Ensures monthly trending is conducted on each product line and reported in the periodic meetings and monthly reports.
• Develops, implements, and continuously improves the system for calibration at the facility. Supports other facilities within FMCNA. Ensures systems conform to company requirements and all applicable state, federal, and international regulations.
• Develops, implements, and continuously improves the system for process/software validation, and design transfer. Ensures these systems conform to company requirements and to all applicable state, federal, and international regulations.
• Develops and maintains a system to integrate calibration, validations, tolerance stacking, risk evaluation, laboratory testing, etc. in order to develop appropriate validation and design transfer requirements.
• Serves as review committee member for calibration systems, process/software validation systems, and design transfer. Reviews process/software validation plans, SRS, SPR, test cases, IQ/OQ/PQ activities, etc.
• Develops and maintains process for first article inspections at Knoxville facility. Provides technical support for other facilities.
• Ensures QS software conforms to the software validation system. Ensures the QS data sources are maintained and administered appropriately to provide the quality records.
• Composes and presents monthly summary reports to management summarizing activities, including trending and graphic representations.
• Provides guidance to plant personnel/management in developing calibration requirements, validation packages, risk management, etc.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends change to policies and establishes procedures that effect immediate organization(s).
• Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers.
• Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action, and terminations.
• Adheres to Company Values: Honesty & Integrity, Quality, Respect & Dignity, Innovation & Improvement, Teamwork & Safety are the guiding principles of employee behavior at FMCNA.
• Provides technical guidance.
• Observe and practice all safety policies and evacuation procedures.
• Maintains general housekeeping of working area and plant.
• Strives to continuously build knowledge and skills.
• Assists with various projects as assigned.
• 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, sit, and walk. Occasionally required to use hands and fingers to handle, feel, reach with hands and arms; talk or hear and wear personal protective equipment that may include safety glasses, hearing protection, hair net, smock, etc. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 35 pounds.
• Occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
• Donning/Doffing is required.

SUPERVISION:

• Responsible for the direct supervision of various levels of Quality Operations staff.

EDUCATION:

• Bachelor’s Degree required in engineering, science, mathematics, statistics, or other technical field; Advanced Degree desirable
• Member of ISPE, PDA, AMMI, ASQC or other trade association helpful.
• ASQ certified Quality Engineer and Manager of Quality/Organizational Excellence preferred.

EXPERIENCE AND REQUIRED SKILLS:      

• Minimum 6 – 8 years of related experience required, preferably with medical device or drug-related manufacturing.
• 3+ years of supervisory or project/program management experience preferred.
• Strong knowledge of FDA regulatory requirements (cGMP/QSR) and of standard quality assurance practices for medical manufacturing operations. Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired.
• Should be familiar with techniques for ensuring data accuracy and integrity, and be able to supervise root cause analysis methods and corrective action investigations.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Knowledge of database software, design software, spreadsheet software, and Word Processing software. SPC Software, MiniTab, Compliancewire, Peoplesoft, and Kronos timecard sign off.
• Regular attendance and maintaining a good attendance record is an essential function of the job.
• Strong verbal and written communication skills.
• Reference ComplianceWire Curriculum.

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.

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.