Product Quality Engineer

The Opportunity:

The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line, supporting testing activities, and supporting packaging validation and finished goods release for robotic devices.

What you’ll do:

Manufacturing responsibilities include:

• Oversee product quality during all stages of production and field service. 

• Ensure compliance with Good Manufacturing Practices (GMP) regulations and internal quality management systems throughout the manufacturing process.

• 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.

• Conduct Material Review Board and participate in materials decision making.

• Establish, implement, and support processes for field service and rework of robotic medical devices. 

• Maintain Device History Records for robotic medical devices

• Support creation of risk management files, including the development of Process FMEA

• Lead and support process validation activities, including IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), for new and existing manufacturing processes.

• Develop validation protocols, execute validation activities, and compile validation reports to ensure process robustness and consistency.

• Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.

• Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.

• Implement Lean and Six Sigma principles to drive continuous improvement initiatives.

Testing responsibilities include:

• Collaborate with cross-functional teams to ensure that design, manufacturing, and standards-based test requirements are met.

• Provide guidance on processes and validations to ensure product safety and compliance.

Packaging and Finished Goods Release responsibilities include:

• Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.

• Participate in finished goods release processes, ensuring compliance with release criteria and applicable 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 audit findings.

What you’ll need:

• Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.

• Minimum of 5 years of experience in a manufacturing quality engineering role within the medical device industry supporting electromechanical capital devices. 

• In-depth knowledge of FDA regulations, ISO 13485, IEC 60601-1, and other relevant quality & safety standards for robotic medical devices.

• Experience with nonconforming material investigations and implementing effective CAPAs.

• Ability to work in a fast-paced environment

Ways to stand out from the crowd:

• Experience supporting development and manufacturing of surgical robotic devices.

• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).

• Familiarity with process validation (IQ/OQ/PQ), electrical safety testing, and packaging requirements for medical devices.

• Strong understanding of GMP regulations and quality management systems.

• Excellent problem-solving skills and ability to apply root cause analysis methodologies.

• 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.

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!