Description

Lead complex validation activities and drive process improvement initiatives 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 defending validation projects and quality initiatives.
• Lead process improvement projects focused on scrap and defect reduction across operations.
• Mentor junior engineers and provide technical support during design, installation, and qualification phases.

Required Skills

• Bachelor's degree in Engineering.
• 3-5 years of engineering experience in Quality, preferably within the Medical Device industry or an FDA regulated environment.
• Proven experience developing and deploying Quality Systems.
• Strong analytical problem-solving skills with experience in Root Cause Investigations.
• Knowledge of FDA cGMP, ANSI/ISO/ASQC requirements, and Lean Six Sigma methodologies.
• Ability to read and understand blueprints and technical drawings.
• Proficiency with CAD and technical software for scheduling and task management.
• Advanced computer competency in Word, Excel, PowerPoint, Minitab, Access, and databases.

Preferred Skills

• Master's degree in Engineering.
• Knowledge of 21CFR820 and CMDAS.

Key Skills

Education

Bachelor's or Master's degrees