Quality Project Engineer
Baxter Medical AB / Maskiningenjörsjobb / Luleå
2025-03-04
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hela Sverige 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.
Liko is part of Baxter, where we are all connected by our mission. Regardless of your role at Baxter, your work has a positive impact on people around the world. You will feel our purpose throughout the organization, as we know that our work improves the results for millions of patients.
Baxter's products and treatments can be found in nearly every hospital worldwide, in clinics and in homes. For 90 years, we have been pioneering significant medical innovations that transform healthcare.
At Baxter, we save and maintain life. Together, we create a place where we are happy, successful, and inspire each other. It is here where you can do your best work.
At our production facility in Alvik, Luleå, we produce personal lifts, lift chairs, and other accessories. Our products are used to lift and transport people in schools, hospitals, and homes worldwide. We won the Swedish Lean Prize 2021, so our Lean work and continuous improvements are a natural part of our business where you will have a meaningful role.
Summary
Do you want to be a part of a company with a mission to save and sustain lives and to make a difference for our clients to accomplish that?
We are searching for a Quality Project Engineer with strong management and analytical skills to our site in Alvik, Luleå.
The Quality Project Engineer role involves ensuring product quality by implementing control and improvement processes within Quality Management. You will complete Quality Engineering Projects and GMP improvements, support other QMS elements and collaborate with the Senior QA Manager to establish, implement, and maintain quality management processes. Your responsibilities include driving data analysis to identify high-priority issues related to safety, regulatory compliance and customer satisfaction and developing improvements opportunities for data-driven decision making.
Essential Duties and Responsibilities
Primary point of contact for Quality Projects and Process Improvement Projects.
Ensuring issues which may require evaluation for possible escalation to CAPA are investigated in accordance with the NCR process.
Implementing CAPA records or act as Quality Approver according to NCR/CAPA procedures when appropriate.
Ensuring that QMS processes are effectively documented and act as Document control change analyst.
Supporting Process and Equipment Validation activities. Ensure that all records of Process validation are effective and appropriate and consistent with existing Quality System requirements and that any failures are properly investigated and dispositioned.
Drive data analysis and analyse performance data to identify high priority issues relating to safety, regulatory compliance, and customer satisfaction.
Working proactively to improve and further develop methods for data driven decision making.
Participate in internal auditing programs as lead auditor and assist with facilitating external audits.
Continually assess and analyse all elements of the quality systems and recommend actions for improvements.
Acting as BaxU learning professional for Luleå Operations.
Perform other duties as assigned.
Qualifications
Bachelor's degree or equivalent experience in an Engineering field, preferable mechanical, electrical, or industrial engineering.
Proven experience in Quality Assurance or Regulatory Affairs, experience in the Medical Device or Pharmaceutical industry is a plus.
Proficient with Quality System Standard, IS013485 and EU Medical Device Regulation.
Experience in Business Intelligence Tools.
Experience of R&D and production site, as well as additional training in Risk Management, Six Sigma, Lean Manufacturing and Statistical Methods is a plus.
Demonstrate ability to succeed in team environments and possess effective interpersonal skills.
Demonstrate attention to detail, analytical decision-making, and problem-solving skills.
Strong management and analytical skills.
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.
Good communication skills, both verbal and written; strategic skills.
Fluent in Swedish and English, other languages are beneficial.
We offer a role where you will be challenged with the opportunity to grow in a world-leading medical technology company. You will work in our facility in Alvik outside of Luleå. We offer lunch at a discounted price at our nearby restaurant, we have a gym and wellness package.
Så ansöker du Sista dag att ansöka är 2025-04-03
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Arbetsgivare Baxter Medical AB (org.nr 556171-0657)
Nedre vägen 100 (
visa karta)
972 52 LULEÅ
Arbetsplats Baxter Liko AB
Jobbnummer 9201278