Post-Market Quality Engineer

Post-MarketQuality Engineer

Now’s our time to inspire the future of healthcaretogether.

SiemensHealthineers is a leading global medical technology company with over 170 yearsof experience and 18,000 patents. More than 48,000 dedicatedcolleagues in over 70 countries are driven to shape the future of healthcare.We stand with our customers around the world to support them in delivering highquality care to their patients. An estimated 5 million patients across theglobe benefit every day from our innovative technologies and services inthe areas of diagnostic and therapeutic imaging, laboratory diagnostics andmolecular medicine, as well as digital health and enterprise services. This iswhat truly matters to us.

Joinour team now at Siemens Healthineers as a Post-Market Quality Engineer.

Thisrole is an ideal opportunity for an ambitious and driven professional who isready to take the next step in their career. As a Post-Market Quality Engineer,you will play a pivotal role in ensuring the ongoing quality and safety of ourproducts within the Point of Care portfolio.

KeyResponsibilities:

·       Yourprimary responsibility will be to evaluate product complaints, determine if aninvestigation is required and ensure each complaint is properly documented.

·       Youwill actively contribute to the continuous improvement of product qualitywithin our Point of Care portfolio by working closely with cross-functionalteams in Research & Development, Supply Chain Management and RegulatoryAffairs to identify and implement product improvements.

·       Youwill conduct data analysis to identify trends, patterns, and assess product risk.

·       Youwill be responsible for monitoring and analyzing key process metrics related topost-market product quality and, when necessary, take actions to improve performance,process efficiency and ensure compliance with regulatory requirements.

·       Youwill support various post market activities to ensure compliance withregulations and standards including participating in audits and inspections.

Required Education and Experience:

·       Abachelor’s degree in a scientific or related technical field is required.

·       Youbring 2-3 years of experience and a proven performance track record.

·       Youhave experience handling complaints in the Medical Device industry andfamiliarity with medical device regulations.

·       Youare a Quality Engineer or Certified Reliability Engineer or Lab technician withdirect experience in Point of Care devices.

·       Clinicalbackground or field experience in a Point of Care or related setting is highly desired.

·       Asolid background in quality assurance principles, practices, and knowledge ofquality management systems (QMS) and relevant standards (e.g., ISO 13485).

Skills required for success in thisrole:

·       Youhave an understanding of scientific and technical concepts, as well asproficiency in analyzing data, identifying patterns, and conducting thoroughresearch to support decision-making processes. Strong problem-solving skillsare essential.

·       Youare an effective communicator in English as you will need to interact withcross-functional teams, present findings, and document assessments clearly.Proficiency in other languages, especially for roles involving internationalcollaboration, can be considered an asset.

·       Stronginterpersonal skills are required, along with the ability to collaborate withcolleagues from various departments, including R&D, regulatory affairs, andmanufacturing.

·       Strongtechnical and problem-solving skills are crucial, as you will frequently assesscomplex situations, make decisions based on available data, and recommendappropriate actions to promptly resolve complaints.

·       Youpay strong attention to detail to ensure accuracy and reliability in your work.

·       Youare self-driven to take the initiative in your tasks, proactively seekopportunities for improvement, and engage in ongoing learning to stay updatedwith regulatory changes and industry best practices.

·       Youenjoy a “hands-on approach” to investigating

·       Youpossess excellent communication skills, both written and verbal, to ensureclear and proper documentation of records.

·       Youmaintain a customer-centric and solution-driven approach.

·       Youare familiar with complaint investigation, Corrective and Preventive Action(CAPA), and Field Action processes is a plus.

·       Youare proficient in Microsoft Office, specifically Excel, PowerPoint, andOneDrive. Additionally, data analytics skills, including PowerBI or similarprofessional analytical software, are expected.

·       Youare a team player and open to learning and working in a collaborative teamenvironment.

AtSiemens Healthineers, we value those who dedicate their energy and passion to agreater cause. Our people make us unique as an employer in the med-techindustry. What unites and motivates our global team is the inspiration of ourcommon purpose: To innovate for healthcare, building on our remarkable legacyof pioneering ideas that translate into even better healthcare products andservices. We recognize that taking ownership of our work allows both us and thecompany to grow. We offer you a flexible and dynamic environment and the spaceto move beyond your comfort zone to grow both personally and professionally.

“Successful candidate must be able to work withcontrolled technology in accordance with US export control law.” “It is SiemensHealthineers’ policy to comply fully and completely with all United Statesexport control laws and regulations, including those implemented by theDepartment of Commerce through the Export Administration Regulations (EAR), bythe Department of State through the International Traffic in Arms Regulations(ITAR), and by the Treasury Department through the Office of Foreign AssetsControl (OFAC) sanctions regulations.” 

If you want to join us in transforming the way healthcareis delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

Ifyou wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

Asan equal-opportunity employer we are happy to consider applications fromindividuals with disabilities.