Position Responsibilities:

Quality Control : Develop manufacturing processes and process controls for in-house and supplier processes. Lead processes related to the receiving and inspection of components, management of inventory, and device assembly builds. Support inspections of incoming materials, in-process components, and finished products to ensure compliance with design requirements.

Design Assurance: Lead quality engineering activities related to product development of the ReValve devices. This will include working with a cross-functional team on defining design inputs/outputs, developing design verification test protocols/reports, performing risk management, supplier development, test methods, and defining inspection criteria.

Risk Management: Participate in risk management activities for early product development to proactively identify potential issues, define requirements, and monitor quality related issues.

Quality Management System: Drive adherence of processes to defined quality management system procedures. Ensure internal quality systems meet required quality standards with a focus on continuous improvement.

Regulatory Compliance: Maintain compliance with regulatory requirements (e.g., FDA, ISO 13485) and company quality standards, ensuring adherence to Good Manufacturing Practices (GMP).

Equipment Calibration & Maintenance: Support the calibration, maintenance, and qualification of testing and production equipment for compliance with relevant standards.

Documentation: Prepare and maintain detailed and well-organized design history file, device master record, and device history record documentation. Lead the completion of technical summaries, inspection reports, non-conformance reports (NCRs), device investigations, and quality records. Ensure proper documentation of test results, test protocols, reports, and associated documentation for both design history and device history files.

Qualifications:

· Bachelor’s degree in engineering, science, or technical discipline required with 2+ years of quality systems experience.

· Experience in quality control, design assurance, or related functions, preferably within the medical device industry.

· Strict attention to detail, with strong problem-solving abilities.

· Strong analytical skills with the ability to identify issues and interpret complex data.

· Ability to manage competing priorities in a fast-paced environment

· Demonstrated ability to work effectively in cross-functional teams and collaborate with manufacturing, engineering, and regulatory departments.

· Hands-on approach with a learning mindset

· In-depth knowledge of FDA regulations, ISO 13485, GMP, and other relevant standards.