Principal Quality Engineer
$106,402–$148,963 year
Remote · United States
Job Summary
Principal Quality Engineer responsible for leading product quality initiatives in a FDA-regulated environment, driving CAPA effectiveness, coaching CAPA site leads, and applying quality tools (Root Cause Analysis, 5 Whys, Ishikawa) to accelerate quality improvements and ensure patient safety and customer satisfaction. The role includes designing and delivering a Design Assurance Quality Engineer training syllabus, supporting high-visibility New Product Development, sustaining engineering, CAPA efforts, high-priority complaint investigations, and regulatory compliance activities, with travel up to 20% and remote work in the US.
Required Qualifications
- BS degree or equivalent in an engineering or life science discipline
- Minimum of 8 years’ experience working in an FDA regulated environment
- Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams
- Proficient with DMAIC/ Lean Six Sigma /Black Belt tools to analyze, drive root cause, and solve difficult problems
- Proficient with statistics, sampling strategies, quality systems trending, and process capability
- Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDAQSRs, ISO 13485, ISO 14971
- Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities
- Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions globally
- Excellent interpersonal, communication (written and oral), presentation and facilitation skills
- Demonstrated ability to coach and mentor others
- Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio)
- Demonstrates the highest ethical standards and actively promotes trust, respect and integrity in all dealings both inside and outside the Company
- Six Sigma Green Belt Certification required
- Ability to travel up to 20% of time domestically and internationally.
Desired Qualifications
- Minimum of 3 years’ experience working in Medical Device or Pharma
- Six Sigma Black Belt is preferred
- Experience in FDA-regulated environments
- Strong leadership, coaching and cross-functional collaboration skills
- Proficient in DMAIC/Lean Six Sigma/Black Belt tools
- Proficient in statistics, sampling, trend analysis, risk management and regulatory requirements (FDAQSRs, ISO 13485, ISO 14971)
- Capable of traveling up to 20% domestically and internationally
- Six Sigma Green Belt Certification required
- Experience with CAPA processes and quality improvement methodologies
- Healthcare/medical device product quality experience
- Strong communication and mentoring abilities
- Experience with Design Assurance Quality Engineering
- Experience supporting high-visibility product development and sustaining engineering
- Root Cause Analysis, 5 Whys, Ishikawa proficiency
- Training and development of quality teams and CAPA site leads
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