Siemens Healthineers · 2 days ago
Quality Engineer
Knoxville, TN
Full-time
Hybrid
Mid, Senior Level
$107K/yr - $147K/yr
5+ years expSiemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Quality Engineer will support site audits, manage quality system metrics, and ensure compliance with regulatory changes while facilitating communication with drug sponsors.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
The support and facilitation of site audits by drug sponsors including gathering/organizing requested information and responding to observations
The support of investigations in conjunction with the manufacturing site and/or drug sponsor
Facilitating communication and approval for exceptions, planned variances, change controls, etc
Managing quality system metric reporting for drug sponsor products
Facilitating and leading meetings with drug sponsors (i.e., routine meetings, quality reviews, etc.)
Ensure compliance with regulatory changes, drug sponsor expectations, and patient/product safety
Qualification
Required
5 years of experience in the sterile injectable pharmaceutical industry
CMO relationship management
Knowledge of 21 CFR 211 regulations and associated sterility assurance guidance documents
Understanding of the drug development process
Experience with MS Office: Word, PowerPoint, Excel and Outlook
Willing to travel and are flexible in responding to changing project priorities
BS/MS in a scientific discipline
Minimum of 5 years of experience in Quality Assurance in the sterile injectable pharmaceutical industry
2 years of experience with cleanroom qualifications and/or design
Prior experience authoring FDA audit responses
Flexible in responding to changing project priorities
Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks
Exercise good judgment in decision-making and sharing of sensitive information
Ability to meet strict timelines
Attention to detail and accuracy
Willing to travel up to 20%
Preferred
A degree in Microbiology is preferred
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
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
Recent News
South Africa Today
2026-01-07
Company data provided by crunchbase