Lead and execute high-impact quality engineering projects that improve product quality, reliability, and compliance.
Develop, implement, and maintain advanced quality control processes, statistical methods, and risk management practices.
Lead complex root cause investigations and corrective/preventive action plans, ensuring systemic issues are addressed.
Partner with engineering, manufacturing, and supply chain teams to design and optimize processes for quality and efficiency.
Provide technical expertise in measurement system analysis, process validation, and statistical process control.
Serve as a subject matter expert during internal audits, regulatory inspections, and customer quality assessments.
Prepare and present quality metrics, trend analyses, and recommendations to senior leadership.
Mentor and coach junior and mid-level engineers, promoting knowledge sharing and development across the team.

Requirements

Bachelor's degree in Engineering, Quality Assurance, Industrial Technology, or a related field with 8–12 years of relevant work experience in quality engineering, process engineering, or manufacturing; OR Master's degree with 5–8 years of relevant experience; OR PhD with 2–5 years of relevant experience.
Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
- GMP quality management systems (e.g. ISO 13485)
- Risk assessment frameworks (e.g. ISO 14971)
- Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
- Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
- Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Benefits

flexible time-off or vacation
401(k) retirement plan with employer match
medical, dental, and vision coverage
carefully selected mindfulness programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality engineeringquality control processesstatistical methodsrisk management practicesroot cause analysiscorrective action plansmeasurement system analysisprocess validationstatistical process controlregulatory compliance

Soft Skills

leadershipmentoringcoachingcommunicationcollaborationproblem-solvinganalytical thinkingpresentation skillsknowledge sharingteam development