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PostMarket Surveillance Quality Associate III

Intake & High Risk/Escalations

PostMarket Surveillance

Quality

Summary

This position is responsible for providing Quality support and oversight as well as identifying, assessing, and working to correct large scope regulatory and quality risks. This position also serves as subject matter expert for PostMarket surveillance complaint handling process for all US products.

Essential Duties and Responsibilities. 

• Serves as a Subject Matter Expert for PostMarket surveillance processes such as complaint handling or Regulatory Reporting
• Assisting in managing daily work assignments and workflows, identifying and escalating issues
• Effectively processing and managing high risk complaint files (e.g. escalated complaints, reports of death or serious injury, atypical events), which includes performing the daily tasks associate with processing these complaint files, including:
• Collecting necessary complaint information and coordinating sample retrieval
• Performing follow-up calls with the customer
• Determining reportabiliy of a complaint
• Partnering with clinicians to obtain input needed to perform reportability determination
• Oversight of investigations and management of escalations to other functions
• Responding to customer complaints (written or verbal), including approval of customer responses as applicable
• Timely closure of complaints, as per procedures
• Coordinating and/or facilitating on site visit, as assigned
• Managing customer escalations related to complaints
• Analyzing PostMarket surveillance complaint information to identify escalations or improvement opportunities
• Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs
• Leading mentoring and training of the PostMarket Surveillance team
• May interface with regulatory agents or internal auditors
• May perform other Postmarket activities as assigned

Qualifications. 

• Strong knowledge of the FDA Quality System and Regulatory Reporting regulations (21 CFR 803, 806, 820, and 211)
• Ability to perform all duties required of previous levels
• Strong interpersonal skills
• Readily accepting of assignments to new/different products
• Ability to prioritize multiple tasks
• Ability to lead people and encourage teamwork
• Customer focus
• Ability to drive decisions quickly and effectively
• Proficient with computers
• Excellent written/verbal communication and organizational skills
• Ability to effectively communicate across multiple levels within the organization
• Ability to make independent decisions with minimum oversight and ability to work independently
• Strong problem solving, critical thinking and analytical skills
• Detail oriented

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

• Bachelor’s degree (life sciences preferred) or clinical certification (MT, RN) or equivalent experience (defined as a minimum of 5 years of medical products industry experience)
• 5-8 years relevant work experience in cGMP related industry or in a clinical setting.
• Experience with driving process improvement initiatives and projects preferred
• Application of lean principles preferred

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.