Senior Quality Engineer

Job Summary

The Sr. Quality Engineer is responsible for leading quality engineering activities that ensure products, manufacturing processes, and quality systems meet all applicable regulatory, customer, and company requirements. This role provides technical leadership for quality initiatives, supports new product development and validation, drives continuous improvement efforts, and partners cross-functionally to improve product quality and manufacturing performance.

Essential Duties/Responsibilities

• Manage and Support Complaints, and CAPAs using Problem Solving & Root-cause Analysis Tools:
  • 5-why Analysis
  • Fishbone Analysis
  • Scheduling Brainstorm sessions
  • Documenting Continuous Improvement Activities
  • Tracing production history throughout ERP, and other systems
• Support Audits:
  • Internal Auditor
  • Subject Matter Expert during external audits
  • Front and Back Room support during customer and process audits
  • Perform supplier audits, support qualification of new suppliers
  • Lead process audits
• Monitor and analyze quality performance and present metrics
• Drive Quality System improvement projects
• Write and revise Forms, Work Instructions and SOP's
• Manage implementation and related change orders
• Train others on process changes
• Support Engineering Development and Validation activities:
  • Process validation
  • Software validation
• Communicate directly with customers throughout:
  • Project meetings
  • Quality issues
• Major quality system improvement projects, CAPA SME
• SME / Coach of specific Quality Processes (Document control, Change Control, Training, Validation)
• Major customer complaints
• Audit SME

Required Skills/Abilities

• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills
• Excellent organizational skills and attention to detail
• Strong understanding of FDA (21 CFR Part 820/QMSR), and ISO 13485 Quality System
• Strong analytical and problem-solving skills
• Strong leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Ability to simplify complex situations and present them with an appropriate level of detail
• Ability to analyze risk and make decisions
• Proficient with statistical software
• Ability to travel as required to Suppliers, Customers, and other events. Up to 10%

Education and Experience

Required: Bachelor's degree in engineering, Quality, Manufacturing, or related technical discipline. 8 years of Quality Engineering experience in a regulated manufacturing environment.

Preferred: ASQ Certified Quality Engineer (CQE). Lean Six Sigma Black Belt certification.