Principal Quality Engineer

Karwell Technologies

Fort Smith, AR

JOB DETAILS
SKILLS
8D, Aerospace and Defense, American Society for Quality (ASQ), Analysis Skills, Best Practices, Biomedicine, Biotech and Pharmaceutical, Certified Quality Engineer (CQE), Change Management, Coaching, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Electricity, Engineering, Engineering Change Order, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), ISO 9001, Leadership, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Manufacturing, Mechanical Engineering, Medical Equipment, Mentoring, Minitab, Presentation/Verbal Skills, Problem Solving Skills, Process Capability, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Product Development, Product Support, Project Engineering, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, Six Sigma Black Belt, Six Sigma Green Belt, Statistics, Statistics Software, Supply Chain Operations, Systems Administration/Management, Technical Leadership, Validation Documentation, Validation Plan, Validation Testing, Vendor/Supplier Evaluation, Writing Skills, eCos
LOCATION
Fort Smith, AR
POSTED
2 days ago
Job Description:
We are seeking an experienced Principal Quality Engineer to lead quality engineering initiatives that ensure compliance, product quality, and continuous improvement across manufacturing and product development processes. The ideal candidate will provide technical leadership in quality systems, risk management, validation, CAPA, supplier quality, and regulatory compliance while partnering with cross-functional teams to drive operational excellence.
Responsibilities:
  • Lead quality engineering activities supporting product development, manufacturing, and sustaining engineering.
  • Develop and implement quality strategies that comply with FDA, ISO 13485, ISO 9001, and other applicable regulatory requirements.
  • Drive root cause investigations and corrective and preventive actions (CAPA) using structured problem-solving methodologies.
  • Lead risk management activities including DFMEA, PFMEA, risk assessments, and mitigation plans.
  • Review and approve engineering change orders (ECOs), design documentation, validation protocols, and quality records.
  • Support design control activities including Design Verification & Validation (V&V), Design Reviews, and Design History Files (DHF).
  • Analyze quality metrics and implement continuous improvement initiatives using Lean Six Sigma and statistical tools.
  • Lead process validation activities including IQ, OQ, PQ, and process capability studies.
  • Collaborate with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations to resolve quality issues.
  • Provide technical leadership during internal, customer, and regulatory audits.
  • Mentor and coach Quality Engineers and cross-functional teams on quality best practices.
  • Support supplier qualification, supplier audits, and supplier quality improvement initiatives.
  • Ensure compliance with cGMP, FDA Quality System Regulation (21 CFR Part 820/QMSR), and applicable international standards.

Requirements:

  • Bachelor's degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, Electrical, Chemical, or related discipline).
  • 8+ years of Quality Engineering experience in a regulated manufacturing environment.
  • Strong knowledge of FDA regulations, ISO 13485, ISO 9001, and cGMP requirements.
  • Experience with Design Controls, Risk Management (ISO 14971), CAPA, Client, and change management.
  • Hands-on experience with process validation (IQ/OQ/PQ), statistical analysis, SPC, MSA, and capability studies.
  • Strong knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
  • Excellent root cause analysis skills utilizing 8D, Fishbone, 5 Whys, and similar tools.
  • Experience leading cross-functional projects and mentoring engineering teams.
  • Strong written, verbal, and presentation skills.

Preferred Qualifications:

  • Master's degree in Engineering or related technical field.
  • ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt.
  • Experience in medical devices, pharmaceuticals, biotechnology, aerospace, automotive, or other highly regulated industries.
  • Experience supporting FDA inspections and ISO certification audits.
  • Knowledge of validation documentation, statistical software (Minitab), and quality management systems.

About the Company

K

Karwell Technologies