Siemens Healthineers · 2 days ago
Quality Assurance Specialist
Dania, FL
Full-time
Onsite
Mid Level
$89K/yr - $123K/yr
3+ years expSiemens Healthineers is a leader in medical technology, dedicated to pioneering breakthroughs in healthcare. The Quality Assurance Specialist will provide oversight for a US site manufacturing radioactive sterile injectables, focusing on GMP investigations, quality audits, and continuous improvement projects.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Providing Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for PETNET Solutions
Focusing on GMP Investigations and CAPA’s, change management, batch release and batch record reviews, site Quality audits and data integrity audits to support PETNET’s Quality oversight functions
Provide on-site support for the purposes of training/mentoring, performing internal and 3rd party quality audits and hosting/support FDA inspections
Serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics
Participate in continuous improvement projects
Manage quality metrics at the site, including focusing on reduction of batch record corrections, investigations, failed batches due to operator error and other quality metrics as assigned
Additional responsibilities include internal form review, inventory management, observations of staff qualifications and facility inspection
Qualification
Required
Experience in the pharmaceutical industry (preferably sterile drug manufacturing) and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11 and/or USP 825
Experience in interpreting regulatory policies and guidance documents and can correctly apply them as appropriate to related activities
Are an expert in the quality assurance disciplines of problem-solving root cause analysis, investigation writing, and management of corrective and preventive actions
Identify procedural gaps and product risk and where appropriate, recommend contingency plans and strategies to mitigate compliance
You have completed studies in Microbiology and/or Analytical Chemistry
Experience with MS Office software (Word, PowerPoint, Excel and Outlook)
Flexibility to travel
Bachelor's degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required
Excellent attention to detail
Be a creative problem solver with the ability to reprioritize multiple times per day while working at the speed of business and delivering results on time
Willing to travel 10% - 25%
Relevant QA experience for 3-5 years in a 21 CFR Part 211 or 212 regulated industry
Preferred
Bachelor's degree in a scientific field (i.e., biology, chemistry, microbiology, pharmacy, etc.) is preferred or equivalent experience required
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
2026-01-16
Company data provided by crunchbase