Senior Quality Engineer

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Senior Quality Engineer (SQE) is responsible for driving compliance with FDA 21 CFR 820, ISO 13485, and other applicable international regulations. This role will play a leadership role in Non-Conformity (NC) management, CAPA investigations, validation activities, and risk management. The SQE will work cross-functionally with manufacturing, engineering, regulatory, and supply chain teams to ensure quality systems are effectively maintained and continuously improved. The SQE works independently with minimal supervision and leads projects and initiatives within the Quality Assurance department. This individual will provide guidance to and mentors junior engineers, technicians, quality staff and cross-functional teams.

RESPONSINILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Non-Conformities Management:

  • Lead the investigation, root cause analysis, and resolution of complex non-conformities (NCs) and Corrective and Preventive Actions (CAPAs).

  • Develop and implement corrective actions to prevent recurrence and ensure long-term compliance.

  • Trend and analyze quality data to identify systemic issues and drive improvements.

• Training Management:

  • Support the development, implementation, and maintenance of the Training Management system.

  • Ensure training programs are up-to-date, compliant, and aligned with Quality System requirements.

  • Monitor training completion and maintain training records for compliance purposes.

• Supplier Management Activities:

  • Assist with supplier approvals, audits, and corrective actions as part of the Supplier Management program.

• Validation and Qualification Activities:

  • Lead the investigation, root cause analysis, and resolution of complex non-conformities (NCs) and Corrective and Preventive Actions (CAPAs).

  • Develop and implement corrective actions to prevent recurrence and ensure long-term compliance.

  • Trend and analyze quality data to identify systemic issues and drive improvements.

• Environmental Monitoring:

  • Support monitoring and reporting activities related to cleanroom environments, vector control, and product bioburden testing.

• Risk Management & Regulatory Compliance

  • Ensure compliance with ISO 14971 by supporting risk management activities.

  • Maintain and enhance the Quality Management System (QMS) to align with ISO 13485, FDA 21 CFR 820, MDSAP, and EU MDR.

  • Participate in external and internal audits, supporting regulatory inspections and remediation efforts.

• Additional Quality Support:

  • Investigate and trend customer complaints and product non-conformances.

  • Develop and maintain inspection programs for incoming, in-process, and final products.

  • Provide technical assistance to cross-functional teams including Marketing, Operations, and Regulatory.

  • Contribute to quality improvement initiatives and lean projects.

• Other Duties:

  • Perform other duties as assigned by management.

QUALIFICATIONS

Education:

• Bachelor’s degree in engineering or a related discipline required.

• Advanced degrees (MS, MBA) or certifications (CQE, Six Sigma, ASQ) preferred.

Experience:

• Knowledge of FDA QSR and ISO Quality Standards.

• 5+ years of experience in Quality Engineering within the medical device, pharmaceutical, or regulated industry.

• Experience leading CAPA investigations and implementing effective corrective actions.

• Strong experience with validation (IQ/OQ/PQ), and risk-based quality methodologies

• Experience with Training Management systems and Non-Conformance processes is preferred.

Skills:

• Strong problem-solving and root cause analysis skills (8D, DMAIC, Ishikawa, etc.).

• Excellent communication and organizational skills.

• Proficient in Microsoft Office Suite (Word, Excel, Outlook).