Quality Assurance Compliance Specialist I
$60,000–$70,000 year
On-siteChelmsford, Massachusetts, United States
Job Summary
Maintain the Quality Management System in compliance with FDA 21 CFR Part 820, ISO 13485, EUMDR, and global regulatory requirements. Assist with CAPA processes, including initiation, investigation support, tracking, and effectiveness verification. Participate in internal audits and support external inspections, including audit readiness activities and tracking nonconformities. Maintain quality documentation in accordance with Good Documentation Practices and support regulatory compliance activities such as UDI data generation and verification. Track training requirements to ensure QMS compliance. Requires a Bachelor's degree in Engineering or Life Sciences, 0–2 years of experience in a regulated industry, and familiarity with FDA QSR, ISO 13485, and CAPA. Salary is $60,000 to $70,000.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related technical field
- Associate degree or technical certification with relevant experience
- 0–2 years of experience in a regulated industry (medical device, pharmaceutical, or biotech)
- Internship, co-op, or academic exposure to quality systems
- Familiarity with global medical device regulations (FDA QSR, ISO 13485, MDR, and/or MDSAP)
- Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP)
- Strong attention to detail and data integrity mindset
- Effective written, verbal, and interpersonal communication skills
- Strong organizational, time management, and prioritization abilities
- Ability to work cross-functionally in a regulated environment
- Foundational understanding of FDA 21 CFR Part 820, ISO 13485, and quality system principles
- Experience with UDI systems and product regulatory compliance processes
- Experience with electronic Quality Management Systems (eQMS)
Desired Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related technical field preferred
- Associate degree or technical certification with relevant experience may be considered
- 0–2 years of experience in a regulated industry (medical device, pharmaceutical, or biotech preferred)
- Internship, co-op, or academic exposure to quality systems strongly preferred
- Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP) preferred
- Strong attention to detail and data integrity mindset
- Effective written, verbal, and interpersonal communication skills
- Strong organizational, time management, and prioritization abilities
- Ability to work cross-functionally in a regulated environment
- Foundational understanding of FDA 21 CFR Part 820, ISO 13485, and quality system principles, preferred
- Experience with UDI systems and product regulatory compliance processes, preferred
- Experience with electronic Quality Management Systems (eQMS), preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.