Senior Principal Engineer

Fresenius Kabi USA

. Develop, implement, and monitor quality metrics at local and global levels .

Posted 10/5/2026full-timeLake Zurich • Illinois • United StatesSenior💰 $130,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance and regulatory compliance within the medical device and pharmaceutical industries, with a strong focus on continuous improvement, risk management, and cross-functional collaboration. Proficient in data analysis and quality metrics to support product development and customer satisfaction.

Highest-signal resume keywords

Quality AssuranceRegulatory ComplianceLean ManufacturingSix SigmaCAPA Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Control ProcessesStatistical TechniquesRoot Cause AnalysisRisk AssessmentProject Management PrinciplesDocument ControlsDesign VerificationDesign ValidationExcel ProficiencyManufacturing Processes

Soft Skills

Excellent Communication SkillsStrong Interpersonal SkillsProblem SolvingLeadership ExperienceCross-Functional Team Collaboration

Tools & Technologies

CAPA ToolsQuality Management SystemsPost Market Surveillance ToolsData Analysis Software

Certifications & Qualifications

CQE Certification

Industry Keywords

Medical Device Industry21 CFR 82021 CFR 21021 CFR 211EN ISO 14971CGMPQSRISO 13485FDA Design ControlHazard Analysis Techniques

About the role

Key responsibilities & impact

Develop, implement, and monitor quality metrics at local and global levels
Identify continuous improvement and customer satisfaction opportunities
Compile and present data for monthly CAPA Review, Product Review meetings, and annual reports
Guide development and implementation of methodologies, processes, and tools for product and process changes
Gather and analyze complaint, CAPA, and SCAR data for root cause analysis
Coordinate CAPA and associated project completion
Work with Engineering and Manufacturing to develop and implement corrective actions
Support Post Market Surveillance through complaint sample evaluations and investigations
Track, trend, and escalate recurring product issues based on complaint data, severity, recurrence, customer impact, and product or patient risk
Coordinate follow-up activities, including CAPAs, design changes, risk management, field corrective actions, and sustaining projects
Serve as primary Quality Assurance contact for customer communications and regulatory inquiries
Perform documented risk assessments and analyses concerning product quality, safety, regulatory impact, and corrective action
Manage local and global product complaints and SCAR responses
Coordinate cross-functional technical investigations with Production Units, R&D, Commercial, Field Service, and other functions
Provide quality support for New Product Development
Influence requirements definitions and ensure reliability, quality, and safety requirements are met
Mentor and coach Engineering on test protocols and reports
Serve as subject matter expert on the Change Review Board and change control process
Ensure regulatory compliance and uphold the quality system
Support internal and external audits
Advise senior management on appropriate actions

Requirements

What you’ll need

B.S. degree in Science or Engineering
8+ years’ experience in the medical device (21 CFR 820) and/or drug (21 CFR 210 & 211) related industry
Minimum 1 year of leadership/supervisory responsibility
Working knowledge of lean manufacturing, Six Sigma, and project management principles
Experience with EN ISO 14971, cGMP, QSR, ISO 13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods
Knowledge of quality control processes and statistical techniques
Understanding of manufacturing processes and techniques
Proficiency with Excel, including PivotTables, trending, and charting
Ability to solve unique and complex problems and exercise sound judgment independently
Excellent verbal and written communication skills
Strong interpersonal skills and ability to work with cross-functional teams
CQE certification a plus
Post Market Surveillance experience a plus
Quality engineering or Product Development experience preferred
Relevant industry experience preferred
Applicants must be authorized to work for any employer in the United States; visa sponsorship is unavailable

Benefits

Comp & perks

Bonus plan with a target of 10% of base salary
401(k) plan with company contributions
Paid vacation, holiday, and personal days
Employee assistance program
Medical, prescription drug, dental, and vision coverage
Life insurance
Disability coverage
Wellness program