Quality Systems Technician I
On-siteIrving, Texas, United States
Job Summary
Coordinate incoming material inspections for all raw and packaging components, verifying conformance against RM and PK specifications. Perform daily spot-checks of process controls, assign lot control identification, and reconcile finished product labels in accordance with established procedures. Document nonconforming components for MRB disposition, prepare samples for internal or external laboratory testing, and maintain accurate QS records and trending data. Participate in cross-functional failure investigations, root cause analysis, and validations as required. Assist with device history record assembly and review, conduct internal audits, and maintain a clean inspection work area while adhering to GMP regulations and FDA standards.
Required Qualifications
- High School Diploma
- 1 year of college or technical school
- 1 – 2 years of related experience in a chemical, food, or drug manufacturing facility, or in a quality related role
- Good organizational skills
- Ability to perform work in a team environment with a minimum level of supervision
- Detail oriented
- Capability to interpret drawings/specifications
- Capability to apply inspection/sampling plans/techniques to verify if materials/components conform to the applicable drawings/specifications
- Aptitude for math with basic algebraic skills and measurement skills
- General knowledge of GMP regulations and standard quality control inspection techniques
- Ability to prepare routine administrative paperwork
- Records maintenance skills
- Knowledge of the structure, policies and procedures of FDA regulated facilities (21 CRD Part 820 Medical Devices)
- Knowledge of Health Canada regulated facilities
- Must be able to lift and/or move up to 50 pounds
- Must be able to effectively lead and coach others
- Strong attention to detail
- Helping customers gives you energy
- Get charged up by interacting with others
- Must be available for weekend shifts
- You believe that food is central to our lives
- Passionate about excellence
- If you have a smile to share, we'd love to have you
- We want amazing humans
Desired Qualifications
- 1 year of college or technical school preferred
- Must have good organizational skills
- Ability to perform work in a team environment with a minimum level of supervision
- Must be detail oriented
- Must be capable of interpreting drawings/specifications
- Must be capable of applying inspection/sampling plans/techniques to verify if materials/components conform to the applicable drawings/specifications
- Must have an aptitude for math with basic algebraic skills and measurement skills
- General knowledge of GMP regulations and standard quality control inspection techniques
- Ability to prepare routine administrative paperwork
- Records maintenance skills
- Knowledge of the structure, policies and procedures of FDA regulated facilities (21 CRD Part 820 Medical Devices)
- Knowledge of Health Canada regulated facilities
- 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
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