Senior Product Quality Engineer

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.
Summary
Now we are looking for a Senior Product Quality Engineer in Alvik, Luleå. This is where you are the quality R&D representative for all design & development areas of our Medical Device products,being a part of our important mission to save and sustain lives. You will partner with the R&D Engineering team in the design maintenance of EU-MDR 2017/745 and FDA patient lifting systems on safe patient handling medical devices to ensure that design control principles are followed, and that safety and efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks.
Essential Duties and Responsibilities:
Provide Product Quality (R&D Quality) assurance support and oversight for in the Patient Support Systems division for medical devices in care environments on patient lifting systems on safe patient handling.
Supporting all Product Quality priorities in multifunctional and international teams for the site Lulea (Sweden) on all Quality and R&D programs. Further support of the Pluvigner (France) and other sites as needed.
Provide quality assurance support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
Ensure compilation and maintenance of product Design History Files in collaboration with R&D.
Partner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust.
Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.
Document traceability of requirements through design output and to design verification and/or design validation.
Insist on early requirements maturation, early test plan/script development, and design input requirements that are indicative of real-world use case environment and customer needs.
Review intended use validation for non-product software and tools used in the development process.
Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.
Perform DHF audits of other products as an independent reviewer.
Support external regulatory and customer audits.
Collaborate with the global Product Quality team to drive continuous improvement, including development of standard work, striving for a world-class Product Development Process.
Ensure R&D Quality aspects of complaints, CAPAs, Field Actions etc. are being handled with highest priority to ensure patient safety, highest quality and compliance.
Audit Support for internal, corporate, and external audits regarding as needed.
Establishment of applied standards as design input for products in collaboration with R&D and assuring conformance to regulations in the area of responsibility.

Qualifications
Bachelor’s degree in Engineering or Computer Science or similar field.
5+ years’ experience in Quality, Software Engineering or related field.
Experience in assessing and developing acc. to procedure to meet Medical Device and Software Connectivity regulatory requirements and guidance’s.
Experience with ISO/ Notified Body audits. FDA inspections is a plus.
Experience in the application of design controls and compliance requirements in accordance with ISO 13485, ISO 14971, EU-MDR 2017/745, IEC 62304, 21 CFR Part 820, 803, & 806, 21st Century Cures Act, NIST Cybersecurity framework, FDA pre and post market cybersecurity guidance.
Professional certification such as ASQ, IEEE, Six Sigma, LEAN manufacturing or achievement of certification. ASQ CSQE preferred.
Strong communication and leadership skills.
Strong, results driven, project management skills.
Excellent problem-solving skills and the ability to teach others.
Capable of clearly presenting and justifying quality position and requirements to management.

Make an impact at Baxter's thriving Luleå site in Sweden. We are dedicated to manufacturing Liko patient lifts, slings, and accessories that enhance the mobility and care of individuals worldwide. Join our award-winning team, honored with the prestigious Swedish Lean Prize 2021, and contribute to a brighter future at Baxter's Luleå site.