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Quality Manager

Req #: JR - 115111 Location: Luleå, Norrbotten County, Sweden Job Category: Quality Date posted: 11/10/2023

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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Quality Manager

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.

As a Quality Manager you ensure product quality through the implementation of various control and improvement opportunities and coordination of work within the area of Quality Management system, CAPA and Learning Management system. Support to Sr. QA Manager in ensuring that processes needed for the quality management system are established, implemented, and maintained. Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.

Essential Duties and Responsibilities

  • Management and further development of the QMS Team
    • Intelligently deploy resources to meet daily business needs in a timely manner while evolving the work processes to become more proactive, efficient, and effective
    • Provide strategic direction and leadership to the team to ensure operations adhere to requirements of compliance and product quality
    • Define and coordinate tasks within the scope of the objective and task definition, as well as review and discuss work results
  • Plan and execute local Audit program
  • Control and track the products and processes quality and regulatory compliance through adequate performance metrics and plans.
  • Stop, if required, the delivery and/or the production of products in case of non-conformity.
  • Ensure that adequate records of data and results concerning tests and product controls are taken
  • Manages effective cross-function relationships and in particular work with concept, product and commercialization teams to ensure quality of product and process.
  • Drive data analysis of performance data to identify high priority issues relating to safety, regulatory compliance and customer satisfaction.
  • Coordination of resources within area of Quality Management system, CAPA and Learning Management system
  • Continuous improvements of processes within area of responsibility
  • Implementation of the company-specific quality policy and quality goals
    • Ensuring product conformity, reducing production deviations
    • Ensuring compliance with design and development activities
  • Communication of the quality principles to promote quality awareness in the company
  • Ensuring compliance with production and process controls
    • Ensuring product conformity, reducing production deviations
    • Ensuring compliance with acceptance and validation activities
  • Management of non-compliant products and investigation of problems with regards to product quality, as well as support for processing: Carry out root cause analyzes, introduce corrective measures to eliminate or reduce the identified causes.
  • Serve as primary point of contact for quality and regulatory issues related to manufacturing processes
    • Lead efforts to identify and execute initiatives to improve manufacturing process and product quality

EDUCATION, EXPERIENCE AND QUALIFICATIONS:

  • Proficient with Quality System Regulations, IS013485, Medical Device Regulation and ISO 13485 Quality System Standards.
  • Demonstrated ability to succeed in team environments and possesses effective interpersonal skills.
  • Demonstrated attention to detail, analytical decision-making, and problem-solving skills.
  • Proven ability to succeed in an environment of continuous improvement and to identify improvement opportunities.
  • Strong customer orientation and excellent written and verbal communication skills.
  • Ability to effectively navigate rapidly changing quality, regulatory and business environments and succeed in an environment of change.
  • Bachelor’s degree (minimum) in an Engineering field, preferable mechanical, electrical, or industrial engineering.
  • 5+ years of experience in Quality Assurance or Regulatory Affairs. Experience in Medical Device or Pharmaceutical industry would be a plus.
  • Strong management and analytical skills
  • Strong process and continuous improvement skills
  • Supportive, positive attitude and approach to work
  • Good communication skills, both verbal and written
  • Able to work independently or as part of a team
  • Strategic skills, ability to holistic/global perspective
  • Additional training in Risk Management, Six Sigma, Lean Manufacturing and Statistical Methods is preferred.
  • Experience of an R&D and production site is a plus
  • Fluent in Swedish and English, other languages are beneficial

Reasonable Accommodations

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 [email protected] 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.

115111

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.

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