Post-Market Quality Engineer
Siemens Healthcare Diagnostics Inc.

Mishawaka, Indiana

Posted in Health and Safety

$58,400.00 - $80,300.00 per year


This job has expired.

Job Info


Post-Market Quality Engineer

Now's our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues 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 high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

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

This role is an ideal opportunity for an ambitious and driven professional who is ready 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 our products within the Point of Care portfolio.

Key Responsibilities:

• Your primary responsibility will be to evaluate product complaints, determine if an investigation is required and ensure each complaint is properly documented.

• You will actively contribute to the continuous improvement of product quality within our Point of Care portfolio by working closely with cross-functional teams in Research & Development, Supply Chain Management and Regulatory Affairs to identify and implement product improvements.

• You will conduct data analysis to identify trends, patterns, and assess product risk.

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

• You will support various post market activities to ensure compliance with regulations and standards including participating in audits and inspections.

Required Education and Experience:

• A bachelor's degree in a scientific or related technical field is required.

• You bring 2-3 years of experience and a proven performance track record.

• You have experience handling complaints in the Medical Device industry and familiarity with medical device regulations.

• You are a Quality Engineer or Certified Reliability Engineer or Lab technician with direct experience in Point of Care devices.

• Clinical background or field experience in a Point of Care or related setting is highly desired.

• A solid background in quality assurance principles, practices, and knowledge of quality management systems (QMS) and relevant standards (e.g., ISO 13485).

Skills required for success in this role:

• You have an understanding of scientific and technical concepts, as well as proficiency in analyzing data, identifying patterns, and conducting thorough research to support decision-making processes. Strong problem-solving skills are essential.

• You are an effective communicator in English as you will need to interact with cross-functional teams, present findings, and document assessments clearly. Proficiency in other languages, especially for roles involving international collaboration, can be considered an asset.

• Strong interpersonal skills are required, along with the ability to collaborate with colleagues from various departments, including R&D, regulatory affairs, and manufacturing.

• Strong technical and problem-solving skills are crucial, as you will frequently assess complex situations, make decisions based on available data, and recommend appropriate actions to promptly resolve complaints.

• You pay strong attention to detail to ensure accuracy and reliability in your work.

• You are self-driven to take the initiative in your tasks, proactively seek opportunities for improvement, and engage in ongoing learning to stay updated with regulatory changes and industry best practices.

• You enjoy a "hands-on approach" to investigating

• You possess excellent communication skills, both written and verbal, to ensure clear and proper documentation of records.

• You maintain a customer-centric and solution-driven approach.

• You are familiar with complaint investigation, Corrective and Preventive Action (CAPA), and Field Action processes is a plus.

• You are proficient in Microsoft Office, specifically Excel, PowerPoint, and OneDrive. Additionally, data analytics skills, including PowerBI or similar professional analytical software, are expected.

• You are a team player and open to learning and working in a collaborative team environment.

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

The pay range for this position is $58,400-$80,300 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is 5% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here : https://benefitsatshs.com/index.html
This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site

"Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations."

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

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

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here .

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here .


This job has expired.

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