Sr Post Market Quality Assurance Associate

Job SummaryProcesses 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) as required to comply with all regulatory obligations. Create reports used for Key Process Indicators (KPI) and aids in the processing of complaints.
Salary Range: $72,000 - $79,000
• 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.
Hybrid role: Onsite 3 days per week
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

Process, analyze, and escalate customer complaints, collecting required information as indicated per internal Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA) regulations.

Collaborate with local Quality Engineers and manufacturing facilities to assess customer complaints and identify issues that could potentially be reportable.  Escalate complaints that are potentially Medical Device Reportable (MDR) to the National Safety Officer (NSO) and Corporate Safety Officer (CSO).  Escalate potential Adverse Drug Event (ADE) or Field Alert Reports (FAR) to the Manufacturing plant for evaluation.

If required, report ADE, MDR and FARs to the FDA. This includes tracking, follow up and closure activities of each event and as back up to the US Vigilance Team.

Ensure investigations conform to the requirements set forth in the global and local SOP’s and in accordance with FDA regulations.

Collaborate with Quality Engineers and Quality Associates on trends and complaint investigation activities as needed.

As required, work with external suppliers and supplier quality personnel on investigation activities associated with complaints related to purchased products. 

Responsible for setting individual work schedule to ensure complaint processing and follow up activities are within the timing guidelines listed in the global SOP for complaint handling.

Perform trend reporting, provide KPI’s and ad hoc reporting based on management requirements.  

Create, update and maintain Post Market Quality Assurance (PMQA) Standard Operating Procedures (SOPs) and Work Instructions (WIs).

Conduct training to complaint handling personnel as needed, to further enhance skills, understanding of product use, and help identify incidents that may lead to reportable events.

Perform other duties as assigned by management to enhance departmental effectiveness and overall operations
 

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) plus ISO 13485/MDSAP, ISO 9001, and EU MDR required.
•    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 the ability to work with cross-functional teams.
•    Strong ability to identify abnormalities/potential problematic areas and provide solutions.
•    Ability to work cross functionally to drive improved business processes and results.
•    SAP experience is strongly preferred.
 

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.