Product Surv Quality Assoc II
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This position also serves as subject matter expert for PostMarket surveillance complaint handling process. This position is responsible for the daily triage and disposition of the Round Lake Corporate Complaint mailbox. This position is also responsible for complaint reconciliation between vendors and Baxter internal partners (e.g. Global Patient Safety).
Essential Duties and Responsibilities
- Responsible for the completion of a daily email assignment and reconciliation for vendor and DSI/Escalation Team
- Assisting with identifying and escalating issues received via the Corporate Complaint Mailbox
- Assisting in complaint reconciliation between vendor or Postmarket Surveillance team and Baxter internal partners (e.g. GPS)
- Overseeing requests for manufacturing review from GPS related to potential safety signals
- Assisting in resolution of escalated issues and risks
- 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.
- May perform other Postmarket activities as assigned
Qualifications for this role
- Strong knowledge of the FDA Quality System and Medical Device 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
- 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 Experience
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.
- Experience with driving process improvement initiatives and projects preferred
Application of lean principles preferred
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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.
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.