Fresenius Kabi
Medical Device
SrEngineer(Quality)
“Sr Engineer (Quality) at Fresenius Kabi. Skills: Quality engineering, Product Development, Medical Device, Drug, cGMP, ISO13485, FDA Design Control, EN ISO14971, statistical techniques, Excel. analyze, implement, and execute processes to ensure product quality. Supports and/or participates in in-depth internal and external audits”
What You'll Achieve.
ensure product quality; timely completion of projects/programs; customer satisfaction; assure CAPAs are opened and completed appropriately; ensure that reliability, quality, and safety requirements are met
Industry & Context.
Analytical and problem solving skills; Gather and analyze data for root cause analysis
Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires.
What They're Looking For.
Must Have
B. S. degree in Engineering, 3+ years’ experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry, Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods, Knowledge of quality control process and statistical techniques, Understanding of manufacturing processes and techniques, Analytical and problem solving skills, attention to detail, Proficient with Excel (PivotTables, trending, charting) and other statistical software, Excellent verbal and written communication skills, Interpersonal skills and the ability to work with cross-functional teams
Nice to Have
Mechanical, Electrical, Biomedical, or Materials preferred, CQE certification a plus, Quality engineering or Product Development experience preferred, Knowledge of lean manufacturing, Six Sigma principles and Project Management a plus
What You'll Do.
and execute processes to ensure product quality
Supports and/or participates in in-depth internal and external audits
Assists with the preparation for Management Review meetings
Monitor various quality metrics
Identify opportunities for continuous improvement and customer satisfaction
Compile and represent data for monthly CAPA Review and Product Review meetings
as well as annual reports
Gather and analyze data for root cause analysis
Drive efforts to assure CAPAs are opened and completed appropriately
Work with Engineering and Manufacturing to develop and implement corrective actions
Support complaint sample evaluations and investigations
Track complaint data to identify actionable trends
Perform risk assessments and analysis
Serves as quality representative for New Product Development
Contribute to requirements definitions and ensure that reliability
and safety requirements are met
Work closely with Engineering to develop test protocols and reports
Actively contribute to Change Review Board as part of change control process
Ensure compliance to regulatory requirements
Uphold quality system
Support internal and external audits
How You'll Work.
Team & Collaboration
working in a cross-functional team environment including but not limited to members from Manufacturing, Clinical, Regulatory, and Marketing; Ability to work with cross-functional teams
Communication Scope
Excellent verbal and written communication skills
Process & Methodology
Utilizes project management skills to ensure timely completion of projects/programs, in support of corporate, plant, and/or departmental goals, Project Management
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