Quality Compliance Specialist (6 month contract)

Ledgent Technology; Tustin (CA); On-site; USD 47,000 - 66,000; Part time

Job summary

Ledgent Technology in Tustin, CA is seeking a detail-oriented Quality Compliance Specialist to maintain our QMS for Class II medical devices. The role ensures development, manufacturing, and post-market activities comply with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR, acting as the primary compliance champion between engineering, operations, and regulatory teams.

This 6-month consulting engagement is 100% onsite, with compensation up to $41 per hour.

Qualifications

• FDA 21 CFR Part 820, ISO 13485, EU MDR knowledge required.
• Experience with internal/external regulatory audits.
• Proficient in eQMS and electronic databases.
• Strong analytical and documentation skills.

Responsibilities

• Maintain the QMS for Class II medical devices.
• Bridge engineering, operations and regulatory teams to ensure compliance.
• Support regulatory audits and regulatory submissions as needed.

Skills

Root-cause analysis

Attention to detail

Regulatory communication

Auditing

Education

Associate degree + 5+ years

Bachelor's degree in science/engineering/medical

ISO Lead Auditor certification

Tools

eQMS

Microsoft Word

Excel

PowerPoint

Job description

6 month consulting contract; might get extended beyond that but no guarantees

No C2C or 3rd party candidates will be considered

100% onsite in Tustin, CA

Max pay is $41 per hour

We are 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.
• 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.