Quality Assurance Jobs at Siemens Healthineers | Apply Now
Quality Assurance Jobs in healthcare are rapidly growing, and Siemens Healthineers is offering an excellent opportunity for professionals seeking impactful careers in the USA. This Quality Assurance Specialist role in Woburn, Massachusetts, gives candidates the chance to work in a global healthcare technology leader while shaping the future of medical innovation. With strong demand for regulated manufacturing expertise, this role promises both career growth and meaningful contribution.
About the Company
Siemens Healthineers is a global medical technology powerhouse with over 72,000 employees across 70+ countries. The company develops advanced healthcare solutions that support clinical decision-making and lifesaving treatments. Siemens Healthineers Careers highlight diversity, innovation, and sustainability. Employees join a world-leading team of scientists, engineers, clinicians, and specialists who are committed to improving patient outcomes everywhere.
Job Details:
- Job Title: Quality Assurance Specialist
- Location: Woburn, Massachusetts, United States
- Category: Engineering
- Job ID: R-25388
- Job Type: Full-Time, Regular
- Base Pay Range: $102,600 โ $153,900
Role Overview
As a Quality Specialist, you will support Quality oversight for a U.S.-based site manufacturing and distributing radioactive sterile injectables (PET) under 21 CFR Part 212 and USP 825 for PETNET Solutions.
Key Responsibilities
- Provide QA oversight for PET sterile injectable manufacturing and distribution.
- Lead and support GMP investigations, CAPAs, change management, and batch release activities.
- Perform batch record reviews, internal audits, and data integrity audits.
- Offer on-site support for training, mentoring, and conducting internal and 3rd-party audits.
- Host and support FDA inspections.
- Serve as a Subject Matter Expert (SME) on assigned QA topics.
- Participate in continuous improvement initiatives.
- Manage site quality metrics, including:
- Reduction of batch record corrections
- Minimizing operator-error investigations
- Supporting improvements in product quality and compliance
- Conduct internal form reviews, inventory checks, staff observations, and facility inspections.
Preferred Background & Experience for Quality Assurance Jobs
This role is a great fit if you bring:
- Experience in pharmaceutical or sterile drug manufacturing, especially PET radiopharmaceuticals under 21 CFR Part 212/11 or USP 825.
- Strong understanding of regulatory policies and guidance documents.
- Expertise in:
- Root cause analysis
- Investigation writing
- Corrective & preventive actions (CAPA)
- Ability to identify procedural gaps, product risks, and recommend compliance strategies.
- Academic background in Microbiology.
- Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
- Willingness to travel as needed.
Required Qualifications
- Bachelorโs degree in a scientific field (biology, microbiology, etc.) or equivalent experience.
- 3โ5 years of QA experience in a 21 CFR Part 211 or 212 regulated environment.
- Excellent attention to detail.
- Strong problem-solving skills with the ability to reprioritize in a fast-paced environment.
- Willingness to travel 10%โ25%.
Benefits Of Quality Assurance Jobs
Eligible employees receive:
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Life insurance
- Short- and long-term disability
- Paid time off, paid sick and safe time
- Paid parking or public transportation support.
