Principal Quality Engineer – Regulatory Excellence Lead

Creative Solutions Services, LLC

Burlington (VT)

On-site

USD 140,000 - 190,000

Full time

14 days+

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Job summary

Creative Solutions Services, LLC in Burlington, VT, seeks a Principal Quality Engineer to lead quality initiatives in a regulated manufacturing environment. You will provide technical leadership for quality systems, CAPA, risk management, process validation, and compliance programs.

You will collaborate with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure products meet customer and regulatory requirements while driving continuous improvement and operational excellence.

Qualifications

Bachelor's degree in engineering or related technical field.
8–15+ years of quality engineering experience in regulated industries.
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP.
Extensive CAPA, investigations, risk management and validation experience.
Experience leading audits with regulatory agencies.
Excellent statistical analysis and problem solving skills.
Proficiency with quality tools including Minitab, SPC, DOE, FMEA, control plans and risk assessments.

Responsibilities

Provide technical leadership to Quality Engineers and cross-functional teams.
Lead investigations into complaints, nonconformances, deviations and quality issues.
Drive root cause analysis using 8D, fishbone, 5 Whys, FTA and FMEA.
Lead CAPA development, implementation, verification and closure.
Ensure compliance with FDA/ISO/GMP requirements.
Support product development including Design Controls, Risk Management, and Validation.
Develop and maintain quality plans, inspection strategies and metrics.
Analyze trends to identify opportunities for process improvement.
Lead internal and external audits and supplier audits.