Sr. Quality Systems Technician

FMG USA Fresenius USA Mfg Inc; Knoxville (TN); On-site; USD 60,000 - 78,000; Full time

Job summary

Fresenius Medical Care is seeking a Quality Auditor to conduct audits of products, ensuring compliance with GMP and ISO-9001 standards, and maintain product integrity.

The role entails following SOPs, documenting records, and assisting cross-functional teams in resolving quality, production, and efficiency issues. Strong organizational and communication skills are essential.

Based in Knoxville, TN, the role offers opportunities for professional growth and cross-site collaboration.

Qualifications

• Knowledge of GMP regulations and ISO-9001 standards.
• Good organizational skills with minimal supervision.
• Proficient computer skills: database, spreadsheet and word processing.
• Strong oral and written communication and attention to detail.

Responsibilities

• Conduct quality audits of products to ensure compliance with GMP and ISO-9001.
• Document records and activities per regulations and SOPs.
• Collaborate with management to resolve quality, production, and efficiency issues.
• Escalate issues to supervisor as needed and maintain code of business conduct.

Skills

Organizational skills

Communication skills

Attention to detail

Mathematical aptitude

Education

High School Diploma

Associate's degree preferred

Tools

Database software

Spreadsheet software

Word processing software

Job description

Purpose and Scope

Conducts Quality audits of products assuring compliance with company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems.

Principal Duties and Responsibilities

Under general supervision, follows established company policies and procedures and applies acquired job skills to fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures. Participates in quality audits to ensure compliance with regulations and internal policies and procedures. Ensures records/activities are properly documented in accordance with regulations. Works on assignments that are moderately difficult, requiring judgment in resolving issues and/or in making recommendations. Follows all policies, guidelines, and Standard Operating Procedures (SOP’s) as required. Performs functions that require full knowledge of general aspects of the job. Maintain a teamwork approach to all tasks and works effectively with other departments. Normally receives no instruction on routine daily work, and general instructions on newly introduced assignments. May provide assistance to lower-level staff with more complex support tasks that require a higher level of understanding of functions, as directed by immediate supervisor. Escalates issues to supervisor for resolution, as deemed necessary. Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. Assist with various projects as assigned by direct supervisor. Other duties as assigned.

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. The position involves moderately active work involving walking and/or standing for considerable lengths of time. Bending to floor level is required and the employee must be able to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level.

Education

High School Diploma required. Associate’s Degree Preferred.

Experience and Required Skills

Minimum 2 – 4 years of related experience. General knowledge of GMP regulations, Must have good organizational skills and be able to perform work with little supervision. Well established computer skills with database, spreadsheet, and word processing programs. Strong oral and written communication skills. Strong attention to detail. Mathematical aptitude is required with a good background in algebraic skills and measurement skills.

Company Information

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.