Sr Quality Engineer

CH01 CHE Fresenius Medical Care (Schweiz) AG; Knoxville, Northern (TN, KY); Hybrid; USD 90,000 - 115,000; Full time

Job summary

Fresenius Medical Care Knoxville seeks a seasoned quality engineer to coordinate investigations, support design control through release, and ensure compliance with regulations. Role emphasizes CAPA, NCRs, and risk management across the product lifecycle.

Bachelor’s degree required; 5–8 years’ related experience (Master’s with 3 years acceptable). Strong statistical skills, DOE, gage R&R, and ability to write technical reports and communicate clearly are essential.

Qualifications

• Bachelor's degree required; Advanced degree desirable.
• 5–8 years of related experience; or a Master’s degree with 3 years’ experience.
• Strong analytical & troubleshooting skills; ability to understand mathematics at an engineering/scientific level.
• Strong technical report writing skills and ability to read and interpret technical documents.

Responsibilities

• Coordinates investigations within the assigned manufacturing plant.
• Implements CAPA, NCR, MCH, and ALH processes and tracks outcomes.
• Performs DOE, correlation/regression analyses, and gage R&R studies.
• Supports design control activities from concept through release.
• Mentors staff and ensures compliance with Code of Business Conduct and policies.

Skills

Analytical skills

Troubleshooting

Mathematics

Technical report writing

Oral and written communication

Education

Bachelor's degree

Master's degree desirable

Tools

MS Office

Job description

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 elevate 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 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

Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.