Post Market Surveillance Quality Associate II

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Your role at Baxter

The Post Market Surveillance Quality Associate II is responsible for processing high risk complaint files as well as providing Quality support and oversight. This position also serves as subject matter authority for Post Market surveillance complaint handling process for all US products.

What you will be doing?

• Serve as a subject matter authority for Post Market surveillance processes such as complaint handling  or Regulatory Reporting
• Assisting in handling daily work assignments and workflows, identifying and raising issues
• Analyzing Post Market surveillance complaint information to identify issues or improvement
• opportunities
• Leading and/or participating in cross functional continuous improvement activities and projects, including NCRs/CAPAs
• Intake of incoming customer calls, and opening complaints from those calls
• Triaging of the Global Corporate Complaints Mailbox
• Timely and accurate processing and disposition of incoming customers’ emails
• May perform other Post market activities as assigned

What do you bring:

• Bachelor’s degree (life sciences preferred)
• 2-5 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
• Solid 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 communication skills
• Readily accepting of assignments to new/different products
• Ability to prioritize multiple tasks
• Ability to lead people and encourage collaboration
• Customer focus
• Ability to drive decisions quickly and effectively
• Excellent written/verbal communication and organizational skills
• Ability to efficiently 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

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
 

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.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. 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, ed