Quality Systems Specialist
$75,000–$85,000 year
Hybrid · Leesburg, Virginia, United States or Allendale, New Jersey, United States
Job Summary
Quality Systems Specialist responsible for developing, maintaining, and continuously improving the QMS to ensure compliance with US and global medical device regulations (FDA, ISO, MDD/MDR). Collaborates cross-functionally to drive CAPA, audits, training, and change control, participates in Management Review and Quality Planning, supports GMP/GDP practices, and assists with internal/external audits. Requires a bachelor’s degree in a related field, strong communication, analytical, and project-management skills, and ability to travel ~10–15%.
Required Qualifications
- Bachelor’s degree in science, engineering, business, or related discipline
- Thorough knowledge of US and International Medical Device Regulations
- Basic knowledge of Quality Systems elements (CAPA, Audits, Management Review, Quality Planning)
- Strong interpersonal, written, and oral communication skills
- Solid analytical, problem-solving, and project management skills
- Demonstrated ability to work effectively in cross-functional team environments
- Ability to travel 10-15% as needed
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