Quality Associate II, Product Surveillance

Baxter International Inc. • Round Lake, IL

5d • $88,000 - $121,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter This position serves as subject matter expert for Post Market Surveillance complaint handling process for all US products. This position is responsible managing customer escalations related to US complaints and performing live calls with the customers to collect additional critical information regarding reported issues to facilitate timely and adequate investigations.

Requirements

• 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)
• 2-5 years relevant work experience in cGMP related industry or in a clinical setting.
• Strong knowledge of the FDA Quality System and Regulatory Reporting regulations (e.g. 21 CFR 803, 806, 820, 211, etc.)
• Strong interpersonal skills
• 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 make independent decisions with minimum oversight and ability to work independently
• Strong problem solving, critical thinking and analytical skills
• Detail oriented
• Applicants must be authorized to work for any employer in the U.S.
• We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• Experience with driving process improvement initiatives and projects preferred
• Application of lean principles preferred
• Ability to perform all duties required of previous levels

Responsibilities

• Serves as a Subject Matter Expert for Post Market 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 reportability of a complaint; Partnering with clinicians to obtain input needed to perform reportability determination; Timely closure of complaints, as per procedures
• Responding to customer complaints (written or verbal), including working with escalated customers
• Managing customer escalations related to complaints
• Analyzing Post Market 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 Post Market Surveillance team
• May interface with regulatory agents or internal auditors
• May perform other Postmarket activities as assigned

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees