Quality Engineer 2
No salary listed
Entry, Junior
Bachelor's
Zapopan, Jalisco, Mexico
Hybrid
Manufacturing Quality & TestQuality Engineering
About the job
Requirements
- A bachelor's degree is required.
- Requires 0 to 2 years of related experience.
- Knowledge of descriptive and inferential statistics, basic probability concepts, the Central Limit Theorem, and the assumptions and robustness of tests.
- Ability to read, analyze, write, and interpret common scientific and technical publications.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Strong computer skills.
- Ability to understand and apply engineering- or scientific-level mathematics.
- Demonstrated analytical and problem-solving techniques for manufacturing-process issues and for product design and use.
- Ability to lift and/or move up to 25 pounds.
- Knowledge of quality records and ability to write inspection records, specifications, and other reports; familiarity with techniques to ensure data accuracy and integrity.
- Knowledge of sampling distributions, including binomial, Poisson, normal, and exponential distributions, and ability to apply statistical inference to each.
- Knowledge of correlation and regression analysis, design of experiments (DOE), acceptance sampling, and the ability to conduct and interpret repeatability and reproducibility (Gage R&R) studies.
- Ability to analyze data using statistical software and quality tools, including risk analysis, flowcharts, control charts, scatter plots, and histograms.
- Ability to apply and incorporate risk-management techniques throughout the product lifecycle.
- Ability to review and comply with the Business Code of Conduct, applicable company policies and procedures, and local, state, and federal laws and regulations.
Responsibilities
- Perform assigned routine tasks under close supervision using established procedures.
- Conduct problem-identification analyses and corrective-action investigations for internal operations, and support problem-identification analyses and corrective actions for suppliers.
- Represent the Quality Department in improvement programs or supplier-collaboration activities.
- Represent the Quality Department on a process-improvement team.
- Maintain general order in the work area and plant.
- Establish stable working relationships internally.
- Refer routine problems to more senior staff for assistance when appropriate and escalate issues to a supervisor or manager for resolution as needed.
- Collaborate on various projects as assigned by the direct supervisor and perform other assigned duties.
- Plan quality activities, conduct internal audits, collect and analyze data, develop and review specifications, and review and qualify designs.
- Work with cross-functional teams to develop, commercialize, and maintain high-quality, innovative, compliant devices; ensure design-control compliance; lead and support product testing and risk management; generate procedures; and serve as a key resource for associated standards and requirements.
About the company
Fresenius Medical Care North America runs a network of dialysis facilities and outpatient labs to deliver coordinated kidney care for hundreds of thousands of patients. It also offers specialty pharmacy and laboratory services and manufactures a wide range of dialysis equipment, disposables, and renal drugs. The company treats patients by providing dialysis and related care at its clinics, supported by the equipment, supplies, and medicines it develops and distributes. FMCNA differentiates itself through its size and integration as the world's largest fully integrated renal company, with a nationwide network covering care delivery, drugs, labs, and manufacturing, aiming to provide high-quality, convenient access to comprehensive services across North America.
Company Size
11-50
Company Stage
Late Stage VC
Total Funding
$40.2M
Headquarters
Waltham, Massachusetts
Founded
1996
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Simplify's Take
What believers are saying
- Q2 2026 operating income rose 23%, showing transformation gains reached profitability.
- FME25+ delivered EUR 67 million savings in Q2 2026 and targets EUR 1.2 billion.
- Real-world evidence studies in July and August 2026 strengthen high-volume hemodiafiltration adoption.
What critics are saying
- The August 2026 outlook disappointed investors after dialysis growth stalled and shares fell 10%.
- FME25+ closed around 100 U.S. clinics in 2026, risking patient leakage to DaVita.
- AB 290 litigation and premium-assistance rules threaten U.S. reimbursement economics and legal spend.
What makes Fresenius Medical Care unique
- Fresenius Medical Care controls dialysis care, equipment, labs, and specialty pharmacy end-to-end.
- Its 5008X CAREsystem reached around 100 clinics and 100,000 treatments by May 2026.
- kinexus and TherapyWise deepen its software moat across home dialysis and kidney therapy.
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Benefits
- Professional Development Budget
- Conference Attendance Budget
- Flexible Work Hours