Description

Lead validation and qualification of equipment and processes in a medical device manufacturing environment.

Responsibilities

• Execute validation lifecycle documentation including plans, protocols, IQ/OQ/PQ, process validation, cleaning validations, and method validations.
• Lead risk assessments using PFMEA and DFMEA to evaluate manufacturing capability and reliability.
• Manage change control activities, investigations, validation deviations, and CAPAs to ensure regulatory compliance.
• Provide technical support to Quality, Regulatory Compliance, and Manufacturing Operations on process controls and GMP/GLP standards.
• Troubleshoot validation problems for equipment and systems while assisting in internal and external audits.

Required Skills

• 5+ years of Quality Engineering experience within a medical device organization.
• Strong background in validation protocols and execution (IQ/OQ/PQ).
• Deep knowledge of FDA Quality System Regulations (QS/QSR) and ISO 13485 requirements.
• Proficiency with statistical tools including Sampling Plans, Experimental Design, and Optimization.
• Experience applying Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Ability to write and review SOPs, work instructions, requirement specifications, and validation reports.
• Experience with supplier quality and managing technical transfers to satellite facilities.

Preferred Skills

• Bachelor of Science in Engineering or an alternative Bachelor's degree with CQE certification.

Key Skills

Education

Bachelor's degree