Reports to: Director of Quality Assurance

Workplace type: Hybrid, 4-day onsite/Friday remote

Description

The Senior Operations Quality Engineer is responsible for providing quality engineering support to IQC, the manufacturing line, supporting finished goods release and development efforts for Versa’s structural heart implant, delivery system and accessories.

Operations Quality Responsibilities Include:

• Oversee product quality during all stages of production.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and drive process improvements.
• Review and provide feedback on material specifications and manufacturing instructions.
• Establish and maintain an effective incoming inspection program for purchased materials, components, and raw materials.
• Supervise inspections of incoming materials, ensuring compliance with specifications and quality standards.
• Participate in materials decision making as a member of Material Review Board.
• Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
• Perform statistical analysis of measurement capabilities, equipment comparisons, process characterization and gauge R&Rs.
• Support process validation activities, including IQ/OQ/PQ for new and existing manufacturing processes.
• Develop validation protocols for in-process and final inspection methods.
• Perform reviews of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.

Design Quality Responsibilities Include:

• Provide quality input to design and clinical readiness reviews and represent Product Quality on cross-functional development teams.
• Collaborate with R&D, Clinical, and Operations to ensure robust design controls, risk management, and V&V execution.
• Participate in the risk management process (FMEA, hazard analysis) and ensure integration into design and manufacturing.
• Ensure compliance with design controls, verification/validation (V&V), and regulatory requirements.

Documentation and Compliance Responsibilities Include:

• Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
• Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.
• Support internal and external audits, including preparation of documentation, participation in audits, and implementation of remedies to audit findings.
• Lead or support QMS improvement and/or certification projects as may be assigned by Director of QA.

Skills

• Strong understanding of quality management systems.
• Excellent problem-solving skills and ability to apply root cause analysis methodologies.
• Experience with different methods of statistical analysis.
• Detail-oriented with effective organizational and documentation skills.
• Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.
• Attention to detail, with a focus on accuracy and precision in quality-related activities.
• Ability to work independently in a fast-paced organization with competing priorities.

Requirements

• Bachelor’s degree in Engineering or a related technical field. Master’s degree is a plus.
• 5-8 years of experience in medical device quality engineering.
• Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.
• Experience working in a cleanroom manufacturing environment preferred.
• Experience with nonconforming material investigations and implementing effective CAPAs.
• Experience working in startup environments is highly desirable.

Why Join Us:

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.