Description

You will provide technical quality support to product teams and manufacturing operations within a regulated environment.

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) to document corrective actions.
• Assist with Corrective & Preventive Actions (CAPA) investigations and customer complaint resolutions.
• Develop and revise quality plans, including incoming, in-process, and final inspection protocols.
• Review and approve Project Design History Files and create technical process documents to maintain FDA and ISO compliance.
• Perform internal audits to ensure quality system compliance.

Required Skills

• Bachelor’s degree in engineering.
• 2+ years of manufacturing quality engineering experience, preferably in medical device, healthcare, or pharmaceutical industries.
• Proficiency with FMEA, CE Diagram, DOE, and MSA.
• Working knowledge of SAP, EtQ, Access, Excel, Microsoft Project, and Minitab.
• Strong technical writing skills for regulatory documentation.
• Knowledge of ISO 13485, ISO 15378, Quality Management Systems, and CFR 21 Part 820.
• Understanding of GDP and cGMP requirements.

Preferred Skills

• ASQ Certified Quality Engineer or ASQ Certified Quality Auditor.
• Six Sigma certification and experience with Lean methodologies.

Key Skills

Education

Bachelor's degree