Quality Compliance Specialist

Quality Compliance Specialist

Seeking a detail-oriented Quality Compliance Specialist to assist the team in maintaining our Quality Management System (QMS) for Class II medical devices. This role ensures all product development, manufacturing, and post-market processes strictly adhere to regulatory frameworks like FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR. The successful candidate will act as a primary champion of compliance, bridging the gap between engineering, operations, and regulatory teams.

Minimum Qualifications:

• Associate degree with 5+ years of medical device industry experience, or a Bachelor's degree in a scientific, engineering, or medical discipline, or ISO Lead Auditor certification.
• Minimum 2-4 years of direct experience in Medical Device Quality Assurance and/or Regulatory Compliance.
• Direct experience handling Class II/Type II medical devices preferred.
• Regulatory Expertise: Deep understanding of FDA 21 CFR Part 820, ISO 13485, and EU MDR.
• Audit Familiarity: Prior experience participating in internal or external regulatory audits.
• Problem-Solving Skills: Strong root-cause analysis capability utilizing tools like 5 Whys or Fishbone diagrams.
• Software Competence: Experience utilizing specialized Electronic Quality Management Systems (eQMS) and electronic databases.
• Computer Skills & Organization: Strong computer skills and excellent organizational abilities required. Proficiency in Microsoft Word, Excel, and PowerPoint is essential, along with the ability to manage multiple tasks, maintain accurate records, and work efficiently in a fast-paced environment.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.