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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters 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:

• Bachelors 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 $88000 - $110000 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 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. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.