MedTech Quality Engineer - Cleanroom & CAPA Leader

Capstan Medical; Santa Cruz (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Capstan Medical is seeking a Product Quality Engineer to support manufacturing lines and finished goods release for structural heart implants, delivery, and robotic devices. The role collaborates with R&D, Regulatory Affairs, and Manufacturing to ensure biocompatibility, sterilization, and packaging standards are met.

The candidate will lead investigations into NCRs, drive CAPAs, and participate in audits and process improvements in a fast-paced, cleanroom environment.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Knowledge of FDA regulations, ISO 13485, and other medical device quality standards.
• Experience in cleanroom manufacturing and nonconforming material investigations.

Responsibilities

• Collaborate with R&D and Regulatory Affairs to ensure biocompatibility requirements are met.
• Provide guidance on sterilization processes and validations for product safety and compliance.
• Facilitate sterilization activities including batch release and validations with third party sterilizers.
• Oversee packaging validation to ensure product integrity during storage and transport.
• Participate in finished goods release processes per release criteria and regulatory requirements.
• Oversee product quality during all production stages in a cleanroom environment.
• Lead investigations into nonconforming materials/products, identify root causes, and implement CAPAs.
• Participate in Material Review Board decisions and cross-functional quality improvements.
• Perform audits of manufacturing processes, inspections, testing, and documentation.

Skills

Quality mgmt systems

Root cause analysis

Documentation

Cross-functional teamwork

Attention to detail

Independent worker

Communication skills

Education

Bachelor's in Engineering

Master's degree (plus)

Job description

Capstan Medical is seeking a Product Quality Engineer to support manufacturing lines and finished goods release for structural heart implants, delivery, and robotic devices. The role collaborates with R&D, Regulatory Affairs, and Manufacturing to ensure biocompatibility, sterilization, and packaging standards are met.

The candidate will lead investigations into NCRs, drive CAPAs, and participate in audits and process improvements in a fast-paced, cleanroom environment.