Job Description

Our client is an exciting, well-funded startup innovator in the cardiac repair space. The Quality Engineer/Sr Quality Engineer will be responsible for developing, applying, revising, and maintaining quality standards for the new product development process.

We are partcularly interested in QEs with prior catheter and/or structural heart and/or surgical robotics product development experience!

Responsibilities

• Oversee product quality during all stages of product development and production in a cleanroom manufacturing environment
• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process
• Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices
• Provide guidance on sterilization processes and validations to ensure product safety and compliance
• Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers
• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes

Qualifications/Experience

• BS/MS in a relevant engineering discipline
• 6+ yrs of relevant medical device R&D and quality manufacturing experience
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices
• Experience with nonconforming material investigations and implementing effective CAPAs
• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are desirable

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