Quality Assurance Specialist Role at Siemens Healthineers USAÂ
Join Siemens Healthineers as a Quality Assurance Specialist in Dania Beach, Florida. Take the next step in your career while ensuring the highest standards in healthcare quality assurance. Work in a supportive and innovative environment that values your expertise and contributions. Explore more quality assurance jobs in the USA.
Job Details:
- Location: Dania Beach, Florida, USA
- Category: Engineering
- Job ID: R-25387
- Job Type: Full-time, Regular
- Salary Range: $89,220 – $133,820
About Siemens Healthineers:
Siemens Healthineers is a global leader in medical technology, employing over 72,000 professionals in 70+ countries. We pioneer breakthroughs in healthcare to improve outcomes for patients everywhere. Our diverse, collaborative team thrives on innovation, inclusion, and sustainability.
Educational Requirements for Quality Assurance Specialist role:
- Bachelor’s degree in a scientific field such as Biology, Chemistry, Microbiology, Pharmacy, or equivalent experience.
- Studies in Microbiology and/or Analytical Chemistry preferred.
Key Responsibilities for Quality Assurance Specialist role:
- Provide oversight for PETNET Solutions’ US site manufacturing and distributing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
- Conduct GMP investigations, CAPAs, change management, batch release and batch record reviews.
- Perform site quality audits, data integrity audits, and support FDA inspections.
- Serve as a subject matter expert for quality assurance topics, including policy and procedure input.
- Participate in continuous improvement projects and manage site quality metrics.
- Conduct internal form review, inventory management, staff qualification observations, and facility inspections.
Skills Required for Quality Assurance Specialist role:
- 3-5 years of experience in a 21 CFR Part 211/212 regulated industry.
- Expertise in problem-solving, root cause analysis, investigation writing, and CAPA management.
- Experience in sterile drug manufacturing or PET radiopharmaceuticals.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).
- Strong attention to detail, creative problem-solving, and ability to reprioritize tasks efficiently.
- Willingness to travel 10%-25%.
Benefits of the Role:
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Life insurance and long/short-term disability coverage
- Paid parking/public transportation
- Paid time off and sick leave
- Professional growth opportunities in a global organization
