Job Details

Overview

Quality Systems Engineer – Facilities (Compliance & Risk Management) role at Siemens Healthineers. The Quality Systems Engineer will play a critical role in ensuring compliance and operational excellence across PETNET facilities by overseeing change control and risk management activities for facility renovations, construction, and maintenance projects. This position serves as the primary quality liaison for project management initiatives, driving the development, evaluation, and approval of SOPs while facilitating cross-functional teams to execute comprehensive risk assessments. The engineer will review and approve facility-related investigations, variances, and change controls, while leading continuous improvement efforts to enhance quality systems and processes.

Responsibilities

• Serving as the Quality Systems change control and risk management liaison for facility-related renovation, construction, and maintenance, ensuring all change control documentation is completed accurately and required risk assessments are documented and approved prior to commencement of facility or equipment changes.
• Providing primary Quality support for project management of facility-related initiatives.
• Developing, evaluating, and approving proposed SOP changes related to facility-related initiatives.
• Facilitating interdisciplinary teams during facility-related risk assessments.
• Reviewing and approving facility-related investigations, variances, change controls, and related documentation.
• Communicating with corporate and site personnel regarding change and risk management issues and initiatives.
• Leading facility-related continuous improvement projects as assigned.
• Partnering and teaming with stakeholders across the organization to address change control and risk management issues and processes.
• Supporting regulatory inspections as needed.
• Performing other quality and regulatory-related duties as assigned or needed.

Minimum Qualifications

• Bachelor's degree in engineering/construction/industrial Hygiene related field or equivalent experience required
• Minimum of 5-8 years of engineering experience; preferably in a pharmaceutical related industry
• Willing to travel up to 25%
• Experienced in facility renovation or construction related projects, change control management and quality risk management in the medical device industry (21 CFR Part 820), or pharmaceutical industry (21 CFR Part 211), and/or PET radiopharmaceutical industry (21 CFR Part 212).
• Experienced in problem solving, root cause analysis, and process improvement activities.
• Experienced in development and management of change control related activities.
• Experienced in Quality Risk Management (QRM) tools and processes.
• Experienced in Project Management.
• You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook).
• You will be working with our latest technology and therefore you are willing to learn about new software and hardware solutions.
• You have very good facilitator and presentation skills.

Who we are

We are a team of more than 73,000 Healthineers in more than 70 countries. As a leader in medical technology, we push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We value diversity and inclusion and work together to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.

Compensation and Benefits

The annual base pay for this position ranges from $86,700 to $130,000, depending on geography, skills, education, experience, and other qualifications. Benefits include medical, dental, vision, 401(k), life insurance, disability insurance, paid parking or public transportation, paid time off, and paid sick and safe time.

Equal Opportunity

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, disability, marital status, pregnancy, genetic information, sexual orientation, gender expression, gender identity, or protected status.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations: Siemens Healthineers will provide reasonable accommodations for persons with disabilities. If you require accommodation, please use the accommodations form or contact HR for assistance.

Job Location

Maryville, TN