Quality Assoc III
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.
Successfully perform all the primary activities as defined in the QAI and QA II job positions. Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, problem solving and team leadership. A functional understanding of FDA, ISO and Baxter Quality systems is also required.
Essential Duties and Responsibilities
- Serves as a Subject Matter Expert for PostMarket surveillance processes
- Leading and/or participating in implementation of the new Standards and Regulations (e.g. EU Medical Device Regulations, MDSAP – Single Audit Program, Postmarket Surveillance Plans, etc.)
- Leading ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities
- Writing, reviewing, analyzing and revising written Procedures and submitting procedural changes as needed.
- Driving global implementation of the PostMarket Surveillance Processes. Partnering with facilities and regions to ensure successful implementation and compliance to procedures / regulations
- Participating in resolution of escalated issues and risks Leading and/or participating in cross functional (including multiple site) continuous improvement activities and projects, including NCRs/CAPA
- Creating and/or analyzing operations metrics and reports to identify improvement opportunities
- Must be a recognized by all levels of the facility as a subject matter expert in their area and be able to demonstrate leadership ability.
- May interface with regulatory agents or internal auditors, including leading audit ready status efforts
- May perform other Postmarket activities as assigned
Qualifications for this role
Good interpersonal/communication (verbal and written) /influencing/negation skills.
Ability to effectively communicate across multiple levels within the organization
- Good project management skills
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Critical Thinking and strong technical, analytical and problem solving skills
- Ability to work independently
- Ability to prioritize and multitask
- Ability to manage people and encourage teamwork
- Ability to drive decisions and actions quickly and effectively
- Ability to make independent decisions
- Collaboration and Teamwork
- Detail Oriented
- Proficient with computers
- Customer Focus
- Strong technical writing skills.
Education and Experience
Bachelor’s degree (Science or Engineering preferred)
5-8 years of experience in Quality, or related field in the medical products industry.
2-3 years of experience in auditing techniques, interpreting regulations and quality system helpful.
Experience with driving process improvement initiatives and projects
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.