Description

You will provide quality guidance, product resolution decisions, and statistical problem-solving for manufacturing operations and new product introduction projects.

Responsibilities

• Lead Material Review Board (MRB) discussions regarding blocked stock and open notifications.
• Investigate Nonconforming Process Reports (NCPR), Situation Analysis (SA), and Health Hazard Evaluations (HHE) with documented corrective actions.
• Assist with Corrective & Preventive Actions (CAPA) and customer complaint investigations.
• Develop and revise quality plans, including incoming, in-process, and final inspection protocols.
• Apply quality engineering practices such as Six Sigma, FMEA, DOE, MSA, and Control Plans to support manufacturing.
• Review and approve Project Design History Files and maintain compliance with FDA and ISO standards.
• Perform internal audits to ensure quality system compliance.

Required Skills

• Bachelor’s degree in engineering.
• Minimum of 2 years of manufacturing quality engineering experience, preferably in a regulated industry (medical device, healthcare, or pharmaceutical).
• Knowledge of regulatory requirements including ISO 13485, ISO 15378, CFR 21 part 820, and GDP/cGMP.
• Experience with statistical tools and methodologies including Six Sigma, DOE, MSA, and FMEA.
• Proficiency with Minitab, Microsoft Project, Excel, SAP, EtQ, and Access.
• Strong technical writing skills for process documentation and validation protocols.
• Ability to make product disposition decisions and manage multiple assignments independently.

Preferred Skills

• ASQ Certified Quality Engineer or ASQ Certified Quality Auditor.
• Understanding of Lean and Continuous Improvement methodologies.

Key Skills

Education

Bachelor's degree