Quality Systems Engineer Facilities (Compliance & Risk Management)

Siemens Healthineers • Kimberlin Hgt, TN

96d • $86,700 - $130,000

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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.

Requirements

• 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.
• Good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook).
• Willing to learn about new software and hardware solutions.
• Very good facilitator and presentation skills.

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.

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree