Senior Post Market Quality Assurance Associate

Fresenius Kabi USA

Processes customer complaints ensuring compliance with FDA regulations. Collaborates with quality engineers for complaint investigation and trend reporting.

Posted 4/16/2026full-timeLake Zurich • Illinois • 🇺🇸 United StatesSenior💰 $72,000 - $79,000 per yearWebsite

About the role

Key responsibilities & impact

Processes complaints to ensure timely and accurate evaluation and completion of customer complaints
May back up the US Vigilance Team with submissions of Field Alert Reports (FAR) and Medical Device Reports (MDR)
Create reports used for Key Process Indicators (KPI) and aids in the processing of complaints
Collaborate with local Quality Engineers and manufacturing facilities to assess customer complaints and identify issues
Escalate complaints that are potentially Medical Device Reportable (MDR) to the National Safety Officer (NSO) and Corporate Safety Officer (CSO)
Ensure investigations conform to the requirements set forth in global and local SOP’s and in accordance with FDA regulations
Perform trend reporting and provide KPI’s and ad hoc reporting based on management requirements
Conduct training to complaint handling personnel as needed

Requirements

What you’ll need

Bachelor’s degree preferred or equivalent work experience
Minimum of 5 years of previous related work experience
Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11)
Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures
Excellent written/verbal communication and organizational skills
Strong computer skills (e.g., Word, PowerPoint, Excel, SAP)
Ability to make independent decisions; strong problem solving and analytical skills
Flexibility to work on new products/assignments
Ability to facilitate training, to coach, mentor and provide effective feedback to team members
Self-motivated and ability to work independently
Exceptional customer focus
Strong interpersonal skills and ability to work with cross-functional teams
Strong ability to identify abnormalities/potential problematic areas and provide solutions
SAP experience is strongly preferred

Benefits

Comp & perks

401(k) plan with company contributions
paid vacation
holiday and personal days
employee assistance program
health benefits including medical, prescription drug, dental and vision coverage

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

complaint processingtrend reportingKPI reportingproblem solvinganalytical skillstraining facilitationcustomer complaint evaluationindependent decision makingregulatory complianceSOP adherence

Soft Skills

written communicationverbal communicationorganizational skillsflexibilityself-motivationinterpersonal skillsteam collaborationcoachingmentoringcustomer focus