The posting
This is a Hybrid position located in Knoxville, TN.
PURPOSE AND SCOPE
Provides technical expertise to the Risk Management Program. Works with risk management team to ensure consistency and to ensure procedures are met. Ensures procedures are clearly defined and implemented to fulfill regulatory and business requirements for all site products/product lines assigned to location/business unit.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Utilizes full understanding of risk management engineering to ensure site compliance to requirements. Partners with Quality Systems staff and drives continuous improvement for effective risk management.
- Develops and maintains risk management files according to applicable regulatory requirements and FMCNA policies and procedures for risk management system. Works to identify areas for continuous improvement of procedures as required.
- Ensures product risk management documentation/files are maintained, with good documentation practices and compliances with quality system for manufactured, refurbished, and distributed products.
- Provides guidance and direction during risk management review meetings as site subject matter expert.
- Provides risk management direction, training, and guidance to staff and applicable departments.
- Analyzes and reports on trends and other areas of quality data, on a periodic basis.
- Develops, implements, and provides technical expertise in overseeing the Risk Management Program for assigned business unit(s), including when and how to develop design and process FMEAs for all manufactured products.
- Facilitates development and completion of product risk assessments.
- Works with the various engineering teams to provide support and direction in risk management.
- Works with risk management and quality teams to ensure consistency and to ensure that procedures are followed.
- Ensures procedures are clearly followed and defined and implemented to fulfill regulatory and business requirements for all site products/product lines.
- Provides guidance and direction on the use of agnatical tools to assess product failure investigations.
- Establishes compliant reporting risk management system to help facilitate timely, accurate, and sustained decision making to ensure appropriate compliant outcomes.
- Works with medical personnel on creation of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.
- Creates reports, as needed, to management summarizing activities, including trending and graphic presentations.
- As required, assumes responsibility for timely completion of Adverse Trend Investigation Reports (ATIRs), including obtaining agreement/commitment to Corrective & Preventive Action (CAPA) recommendations.
- Ensures all product risk management files are compliant to company procedures.
- Ensures FDA regulations and commitments are followed at all times during process improvement activities.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Networks with senior internal and external personnel in own area of expertise.
- 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.
- Travel is approximately 10%.
EDUCATION
- Bachelor’s Degree required in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Science, or similar field; Advanced Degree desirable.
- Formal risk management training by recognized training intuition desired.
- Certified Quality Engineer preferred.
EXPERIENCE AND REQUIRED SKILLS
- Minimum 5 – 8 years of related experience in Risk Management and/or Quality Systems/Design Control in the medical device or pharmaceutical industries; With a Master’s Degree 3 years of experience required.
- Required- English fluency. Preferred- Bilingual (English/Spanish).
- Knowledge and application of quality systems, design controls, and risk management system requirements to comply with regulations and standards.
- Proven effective leadership and influencing skills.
- Good team work and interpersonal skills.
- Strong project management and organizational skills.
- Excellent verbal and written communication skills.
- Strong analytical and problem solving skills.
- Excellent attention to detail.
- Resourceful, self-reliant, self-motivated, and confident
- Understanding and application of FDA and ISO audits
- PC based computer skills especially data management systems such as Access and Excel.
- Regular attendance and maintaining a good attendance record is an essential function of the job.
Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.
Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors
