Analyst II, Quality Compliance

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

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 chi