Senior QA Engineer - MedTech Compliance & QMS (Hybrid)

MedAcuity, LLC; Westford, Northern (MA, KY); Hybrid; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HRA

FSAs

401(k) with company match

Life and disability insurance

Voluntary life insurance

Employee assistance programs

Recognition awards

Vacation and sick time

Job summary

MedAcuity, LLC is seeking a Senior Quality Assurance Engineer to join our MedTech-focused teams. You will audit and improve QMS processes, develop vital quality documentation, and drive compliance across design and development artifacts.

You will collaborate with internal and client teams, lead risk analyses, CAPAs, and training to ensure alignment with 21 CFR Part 820, ISO 13485, and ISO 14971, while supporting audits and continuous quality improvements.

Qualifications

• 8+ years in QA/regulatory in medical device with software focus.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 9001, IEC 62304, IEC 81001-5-1, and ISO 14971.
• Experience with QMS improvements, documentation, and DHF gap analysis.
• Production QA in medical device/pharma regulated fields.
• Experience communicating with internal/external stakeholders.
• Proficiency with CAPAs and root cause analysis.

Responsibilities

• Lead and audit QMS elements across design and development artifacts.
• Develop and improve SOPs, VMPs, Verification and Validation Plans, Risk Management Plans, and CAPAs.
• Ensure compliance with 21 CFR Part 820, ISO 13485, risk management.
• Provide QA regulatory support to teams and clients.
• Lead risk analysis and CAPA processes.
• Deliver training materials for engineers and leadership.
• Support internal and external audits.

Skills

QA / Regulatory experience

Software process compliance

Root Cause analysis

CAPA management

Education

Bachelor's degree in CS/EE or related

Tools

eQMS

MasterControl

Arena

Veeva

Job description

MedAcuity, LLC is seeking a Senior Quality Assurance Engineer to join our MedTech-focused teams. You will audit and improve QMS processes, develop vital quality documentation, and drive compliance across design and development artifacts.

You will collaborate with internal and client teams, lead risk analyses, CAPAs, and training to ensure alignment with 21 CFR Part 820, ISO 13485, and ISO 14971, while supporting audits and continuous quality improvements.