Description

You will manage supplier quality control and documentation reviews to ensure regulatory compliance for new product development.

Responsibilities

• Review DHf, Core documents, and engineering drawings to ensure production readiness and regulatory clearance.
• Execute supplier quality audits to ensure compliance with FDA QSR, ISO 13485, and internal procedures.
• Drive supplier working documents including PFMEAs, process flows, control plans, inspection plans, and capability studies.
• Develop and implement corrective and preventive action plans, including internal CAPAs and supplier SCARs.
• Design inspection methods, equipment, acceptance criteria, and sampling plans to support qualified vendors.
• Provide statistical analysis and validation support for mechanical testing, manufacturing processes, packaging, and sterilization.
• Participate in cadaver labs for design freeze during new product development.

Required Skills

• Experience with PFMEA and CMM correlation studies.
• Knowledge of FDA QSR and ISO 13485 requirements.
• Proficiency in managing CAPA and supplier SCAR processes.
• Experience with gage RRs, special process validations, and DHR reviews.
• Ability to perform statistical analysis for product clearance and validation.
• BS in Mechanical Engineering with 6 years of experience, or MS in Mechanical Engineering with 1 year of experience.
• Background as a Quality Engineer, Validation Engineer, or Process Engineer.
• Willingness to perform frequent domestic travel.

Key Skills

Education

Bachelor's degree