Engineer II, Quality

Overview

The Manufacturing Quality Engineer (QE) provides oversight and guidance to manufacturing operations by ensuring compliance with industry standards and quality system regulations. The QE coaches manufacturing and cross-functional personnel on proper cGMP requirements to help manufacture high-quality products. The QE applies Quality Engineering Principles and Continuous Improvement Tools to drive systemic improvements in Manufacturing Operations and Quality Systems, and ensures compliance effectiveness.

Project management principles are used to drive timely delivery of results and resolution of quality issues through cross-functional collaboration, communication, and leadership across organizational levels. The QE performs scheduled Safety Inspections.

Manufacturing Quality & Continuous Improvement

• Owns or drives non-conforming reports (NCMRs/NCRs) and CAPAs from initiation to closure.
• Performs NCMR tracking and trending (data analysis) to identify improvements for systemic issues.
• Uses problem-solving tools (e.g., 5 Why’s, Ishikawa) to perform root cause investigations.
• Ensures maintenance or updating of risk documents such as PFMEAs, DFMEAs, etc.
• Ensures compliance with Quality System Regulations (e.g., QSR 21 CFR 820 and ISO-13485).
• Supports qualification activities such as IQ, OQ, PQ;
  Test Method Validations (TMV), Gage R&R/MSA.
• Performs statistical analysis of various manufacturing data using tools such as Minitab.
• Drives decision making to resolve manufacturing quality or systems-related issues.
• Improves overall manufacturing processes to reduce internal and external escapes.
• Creates, reviews, or revises procedures for manufacturing processes and quality systems.
• Conducts Gemba walks to identify compliance risks and propose mitigations.
• Acts as QE liaison for ICU Medical customers (products supplied to internal and external customers).
• Drives outgoing product quality improvements using quality engineering principles.
• Resolves internal and external customer quality issues and provides technical assistance for products.
• Interfaces with external suppliers to resolve supplier quality issues as needed.
• Provides oversight for satellite locations as assigned.
• Creates data analysis charts, Pareto charts, management slides, and presents to leadership.

Project Management

• Creates action plans, project plans or roadmaps to resolve issues.
• Collaborates cross-functionally and across various levels and geographies.
• Drives timely resolution of issues and completes projects in a timely fashion.
• Leads or supports cross-functional initiatives as a Quality Engineering Subject Matter Expert.
• Participates in meeting departmental goals and objectives.
• Conducts Safety Inspections and takes prompt action to eliminate work hazards.
• Performs other related duties as assigned or required.

Knowledge, Skills & Qualifications

• Experience with technical writing related to NCMRs, CAPAs, engineering investigations and analysis.
• Experience reading engineering drawings and quality documentation.
• Experience with PFMEAs, DFMEAs, UFMEAs, Product Hold Orders, Issue Impact Assessments, Risk Assessments.
• Experience with Minitab or similar statistical tools; SPC experience.
• Experience with 21 CFR 820 and ISO-13485 or ISO
  9001 or equivalent standards.
• Knowledge of Lean Manufacturing (TPS), Standardized Work, First Time Quality, Kaizens.
• Strong analytical skills and problem-solving ability through analytical reasoning.
• Strong attention to detail and accuracy in mitigating product quality and business risks.
• Experience working in a cross-functional, fast-paced manufacturing environment across all levels.
• Strong interpersonal skills and a track record of teamwork, adaptability, innovation, and self-motivation.
• Strong project management skills and ability to balance multiple priorities.
• PC skills, word processing, spreadsheets, project management tools.

Education and Experience

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited college or university is required, preferably in Engineering or STEM. Other areas may be considered based on experience.
• Previous regulated industry experience preferred.
• Experience in a clean room environment…