Analyst II, Quality Compliance

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.

Essential Duties and Responsibilities:

• Develop and sustain the Quality Management System in line with the required regulatory, industry standards (ISO 13485) and business needs.
• Implements, maintains and administrates Quality Systems procedures, standards and systems.
• CAPA Review Board Meeting - compilation of slides, drive action items and presentation of content
• Management Review - compilation of slides, drive action items and presentation of content
• Annual Product Quality Review - compilation of data and completion of report
• New Hire Orientation - maintain documentation and administer Quality Training
• Perform internal audits.
• Knowledgeable of the QMS KPIs for management review meetings and other platforms as needed.
• Support and execute improvement projects within the following systems as needed:
  • Change Control - assessments, approval, management
  • Document Control - controlled forms, periodic review, QMS Compliance
  • Training - management of system, improvements, compliance
  • Compliance - internal & external audits, site certifications, global & regulatory compliance, field actions
  • Audit - support with coordination, host and respond to internal & external audits. Train/prepare site staff for audits.
  • Support global initiatives for site improvements (PROsite Model, GOC) working cross-functionally to address issues and implement improvements.
• Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Initiate and/or own nonconformance reports and support investigations as needed.
• Other duties, tasks or projects as assigned.

Qualifications:

• Must have very strong verbal and written communication skills, documentation practices (cods), be self-motivated and possess strong interpersonal skills.
• Must be able to update procedures and modify processes to simplify their complexity and improve efficiencies.
• Must be experienced with interpreting quality system regulations.
• CQA, ISO 13485 Auditor certifications are a plus.
• Team Player with strong interpersonal/management skills
• Excellent problem-solving skills, attention to detail, verbal and written communication
• Good project management skills
• Working knowledge of FDA/ISO Regulations (ISO 13485, 21 CFR 820 Quality Management System regulations), Application of Good Documentation Practices and Application of Good Manufacturing Practices

Education and/or Experience:

• BS in science or engineering preferred
• 3+ years' experience in Quality, Manufacturing, Engineering, or related field.
• Must be experienced with interpreting quality system regulations. Audit experience is helpful, but not required.

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 employees.For 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.