Description

Lead complex validation activities and drive process improvement projects within a regulated manufacturing environment.

This role is on-site.

Responsibilities

• Execute IQ, OQ, PQ, and MSA protocols and reports for processes, equipment, test methods, and computerized systems.
• Drive change control processes to ensure alignment with procedural and regulatory requirements.
• Represent the quality function during external audits by presenting and defending validation projects.
• Lead process improvement initiatives focused on scrap reduction, defect reduction, and operational efficiency.
• Mentor junior engineers and provide technical support during design, installation, and qualification phases.

Required Skills

• 5+ years of engineering experience in Quality, ideally within the medical device industry.
• Experience in FDA regulated environments with knowledge of 21CFR820.
• Strong background in Root Cause Investigations and analytical problem solving.
• Proficiency in reading and understanding blueprints and technical drawings.
• Experience with Lean Six Sigma process improvement methodologies.
• Technical proficiency in CAD and engineering principles.
• Advanced computer competency in Word, Excel, PowerPoint, Minitab, Access, and databases.

Preferred Skills

• Master’s degree in Engineering.
• Knowledge of CMDAS, ANSI, ISO, or ASQC requirements.

Key Skills

Education

Bachelor's or Master's degrees