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Mgr, Quality Ops, Engineering, Assurance

Req #: JR - 125545 Location: Hayward, California, United States Job Category: Quality Date posted: 02/01/2024

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Mgr, Quality Ops, Engineering, Assurance

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. 

Your Role at Baxter

Day-to-day activities of the Quality Operations, Inspections/Release, and Quality Engineering. This person will handle cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations.

What you'll be doing

  • Implementation and improvement of Quality Processes that will assure compliance with Regulations, Corporate and Local procedures, and specifications.        

  • Quality Representative in the manufacturing areas.

  • Manage the batch review and release activities.

  • Interfaces with regulators during regulatory inspections/ audits.

  • Identifies and manages continuous Improvement and VIP projects with the objective of achieving quality, reliability, and cost Improvements.

  • Ensure adherence to budget.

  • Support change control activities for manufacturing operations.

  • Manage the release process, inspection, and batch release activities.

  • Oversee, initiate, investigate and approve non-conformance report activities as needed.

  • Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.

  • Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements.

  • Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.

  • Interacts frequently with all levels of internal management as well as across functions and franchises.

  • Manages overall coaching, training, development and succession plans for the team.

What you'll bring

  • BS in science or engineering. 5+ years’ experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience in a Medical Device or Pharma Industry.   

  • Good working knowledge of applicable quality and regulatory standards and regulations

  • Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

  • Thorough knowledge of applicable procedures, specifications, regulations, and standards.

  • Strong leadership skills and demonstrated success in managing mid to large teams. Capable of managing in matrix and ability to interact successfully with multi-functions globally.

  • Strong analytical and problem-solving skills.

  • Good project management skills.

  • May perform other duties as assigned.

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 $104,000 - $143,000 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. 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.

#LI-KV1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

125545

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.

Christelle

Meet Lorena, Senior QA Associate in London, UK

I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.

Lorena

Meet Gary, Quality Research Manager in Singapore

I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.

Lorena

Meet Lorena, Senior QA Associate in London, UK

I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.

Gary

Meet Gary, Quality Research Manager in Singapore

I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.

Join Our Talent Community

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