Product Quality Engineer

Description

We are seeking a highly skilled and motivated Quality Engineer to join our team. The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line, coordinating biocompatibility and sterilization validation activities, and supporting packaging validation and finished goods release for structural heart implant, delivery, and robotic devices.

Manufacturing Quality responsibilities include:

• Oversee product quality during all stages of production in a cleanroom manufacturing environment.
• 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.
• 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.
• Participate in materials decision making as a member of Material Review Board
• 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.

Biocompatibility & Sterilization responsibilities include:

• 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.

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.

Skills:

• Familiarity with process validation (IQ/OQ/PQ), biocompatibility, sterilization, 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.
• 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.
• Minimum of 7 years of experience in a manufacturing quality engineering role within the medical device industry. Experience with structural heart, delivery catheter, and/or robotic products is desirable.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.
• Experience working in a cleanroom manufacturing environment.
• 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.