Quality Engineer
@ 301044 Fresenius Kabi USA, LLCQuality Engineer
About the job
Fresenius Kabi is a global healthcare company. The Quality Engineer role focuses on ensuring manufacturing quality, conducting analysis, and maintaining standards in a regulated environment.
Requirements
- Statistical analysis skills
- Validation troubleshooting
- Instrument maintenance experience
- Knowledge of quality standards
Qualifications
- Bachelor's degree
- English proficiency
- Attention to detail
Full job description
Job Summary
Develops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analysis, and verifies instrument maintenance, potentially assisting in establishing corporate validation policies.Responsibilities
The Professional performs some or all of the following accountabilities as assigned:
• Developing and evaluating quality and system standards to ensure reliability and compliance with company standards and governmental regulatory requirements
• Investigating/troubleshooting validation discrepancies for systems and/or performance processes
• Conducting statistical analyses of testing results and process anomalies
• Writing, reviewing, approving and/or executing documentation for new and current validation procedures and technical reports related to systems, products and/or processes
• Ensuring corrective measures meet acceptable reliability standards
• Verifying calibration, maintenance and repair of instruments
Salary range between $80,000 - $110,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
- Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
- The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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