Senior Post Market Quality Assurance Associate
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: Lake Zurich • Illinois • United States
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Salary
💰 $72,000 - $79,000 per year
Job Level
About the role
- 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
- 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
- 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
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